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Siemens Healthcare Diagnostics, Inc.

153 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Atellica CH Acetaminophen 2 (ACTM) (K261364)Siemens Healthcare Diagnostics, Inc.2026-07-24
Atellica CH Diazo Total Bilirubin (D_TBil) (K251998)Siemens Healthcare Diagnostics, Inc.2026-02-27
Atellica® IM TSH3-Ultra II (TSH3ULII) (K251543)Siemens Healthcare Diagnostics, Inc.2026-02-06
Atellica IM Total PSA II (tPSAII) (K251630)Siemens Healthcare Diagnostics, Inc.2026-01-05
ADVIA Centaur Anti-Thyroglobulin II (aTgII) (K250816)Siemens Healthcare Diagnostics, Inc.2025-12-04
ADVIA Centaur Anti-Thyroid Peroxidase II (K250250)Siemens Healthcare Diagnostics, Inc.2025-10-17
Atellica IM Thyroglobulin (Tg) (K242981)Siemens Healthcare Diagnostics, Inc.2025-06-20
Atellica® CH Creatinine_3 (Crea3) (K242685)Siemens Healthcare Diagnostics, Inc.2024-12-04
Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) (K241800)Siemens Healthcare Diagnostics, Inc.2024-07-26
Atellica® IM High-Sensitivity Troponin I (TnIH) (K241165)Siemens Healthcare Diagnostics, Inc.2024-07-25
ADVIA Centaur® TSH3-Ultra II (TSH3ULII) (K233050)Siemens Healthcare Diagnostics, Inc.2024-04-04
Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) (K233242)Siemens Healthcare Diagnostics, Inc.2024-01-18
ADVIA Centaur® NT-proBNPII (PBNPII) (K220265)Siemens Healthcare Diagnostics, Inc.2023-09-24
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) (K222439)Siemens Healthcare Diagnostics, Inc.2023-08-08
Emit® II Plus Buprenorphine Assay (K221605)Siemens Healthcare Diagnostics, Inc.2023-07-25
A-LYTE® Integrated Multisensor (IMT Na K Cl) (K222438)Siemens Healthcare Diagnostics, Inc.2023-07-25
Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) (K222116)Siemens Healthcare Diagnostics, Inc.2023-07-13
Atellica® CH Diazo Direct Bilirubin (D_DBil) (K223078)Siemens Healthcare Diagnostics, Inc.2023-06-12
ADVIA Centaur® Anti-Müllerian Hormone (AMH) (K221801)Siemens Healthcare Diagnostics, Inc.2023-06-02
Atellica® CH Diazo Total Bilirubin (D_TBil) (K222104)Siemens Healthcare Diagnostics, Inc.2023-03-20
RCRP Flex reagent cartridge (K221119)Siemens Healthcare Diagnostics, Inc.2023-03-17
Dimension EXL LOCI BRAHMS Procalcitonin (PCT) (K220262)Siemens Healthcare Diagnostics, Inc.2022-08-26
Atellica CH Enzymatic Creatinine_3 (ECre3) (K212223)Siemens Healthcare Diagnostics, Inc.2021-11-24
ADVIA Centaur Enhanced Liver Fibrosis (ELF) (DEN190056)Siemens Healthcare Diagnostics, Inc.2021-08-20
ADVIA Centaur® Digoxin assay (K193397)Siemens Healthcare Diagnostics, Inc.2021-07-16
ADVIA Centaur® Total hCG assay (K200210)Siemens Healthcare Diagnostics, Inc.2021-07-13
ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay (K200256)Siemens Healthcare Diagnostics, Inc.2021-07-02
ADVIA Centaur Vitamin D Total (VitD) (K200509)Siemens Healthcare Diagnostics, Inc.2020-05-29
ADVIA Centaur CA 125II (K200199)Siemens Healthcare Diagnostics, Inc.2020-04-06
RAPIDPoint 500e Blood Gas System (K192240)Siemens Healthcare Diagnostics, Inc.2020-03-27
ADVIA Centaur BR (K193489)Siemens Healthcare Diagnostics, Inc.2020-02-13
ADVIA Centaur Total IgE (tIgE) (K193493)Siemens Healthcare Diagnostics, Inc.2020-01-15
ADVIA Centaur Cortisol (COR) (K192788)Siemens Healthcare Diagnostics, Inc.2019-11-25
ADVIA Centaur CA 15-3 assay (K192777)Siemens Healthcare Diagnostics, Inc.2019-11-22
Atellica IM Total hCG (ThCG) (K192790)Siemens Healthcare Diagnostics, Inc.2019-10-30
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (K191533)Siemens Healthcare Diagnostics, Inc.2019-08-28
Atellica CH Amylase_2 (AMY_2) (K191454)Siemens Healthcare Diagnostics, Inc.2019-07-30
ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control (K191578)Siemens Healthcare Diagnostics, Inc.2019-07-17
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay (K190675)Siemens Healthcare Diagnostics, Inc.2019-05-17
Dimension Vista High-Sensitivity Troponin I (TNIH) Assay (K182225)Siemens Healthcare Diagnostics, Inc.2019-03-04
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control (K181213)Siemens Healthcare Diagnostics, Inc.2018-07-30
Atellica IM High-Sensitivity Troponin I (TNIH) (K171566)Siemens Healthcare Diagnostics, Inc.2018-07-19
Atellica IM BRAHMS Procalcitonin (PCT) (K181002)Siemens Healthcare Diagnostics, Inc.2018-07-16
Dimension Hemoglobin A1c Assay (K173909)Siemens Healthcare Diagnostics, Inc.2018-07-13
ADVIA Centaur High-Sensitivity Troponin I (TNIH) (K171274)Siemens Healthcare Diagnostics, Inc.2018-07-12
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) (K181082)Siemens Healthcare Diagnostics, Inc.2018-05-25
Atellica IM Folate Assay (K172201)Siemens Healthcare Diagnostics, Inc.2018-04-12
Atellica IM Total hCG (ThCG) (K172322)Siemens Healthcare Diagnostics, Inc.2018-03-29
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay (K171771)Siemens Healthcare Diagnostics, Inc.2017-12-04
Emit II Plus Cocaine Metabolite Assay (K170293)Siemens Healthcare Diagnostics, Inc.2017-10-25
Emit II Plus Oxycodone Assay (K172910)Siemens Healthcare Diagnostics, Inc.2017-10-18
Atellica IM Ferritin Assay (K171642)Siemens Healthcare Diagnostics, Inc.2017-08-31
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay (K163658)Siemens Healthcare Diagnostics, Inc.2017-05-23
Atellica CH Phencyclidine (Pcp) (K163220)Siemens Healthcare Diagnostics, Inc.2017-04-06
ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) (K170065)Siemens Healthcare Diagnostics, Inc.2017-03-09
Atellica CH Magnesium (Mg) (K162399)Siemens Healthcare Diagnostics, Inc.2017-01-19
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) (K161494)Siemens Healthcare Diagnostics, Inc.2016-11-15
ADVIA Centaur HAV IgM Assay (K161964)Siemens Healthcare Diagnostics, Inc.2016-10-13
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator (K160724)Siemens Healthcare Diagnostics, Inc.2016-09-07
ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material (K151986)Siemens Healthcare Diagnostics, Inc.2016-06-29
IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 (K160647)Siemens Healthcare Diagnostics, Inc.2016-05-31
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) (K160202)Siemens Healthcare Diagnostics, Inc.2016-04-27
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material (K152061)Siemens Healthcare Diagnostics, Inc.2016-03-03
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator (K151529)Siemens Healthcare Diagnostics, Inc.2016-02-11
ADVIA Centaur Toxoplasma M (Toxo M) (K142826)Siemens Healthcare Diagnostics, Inc.2015-12-22
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator (K153365)Siemens Healthcare Diagnostics, Inc.2015-12-18
Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator (K151767)Siemens Healthcare Diagnostics, Inc.2015-12-11
Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System (K151792)Siemens Healthcare Diagnostics, Inc.2015-11-20
Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive (K150606)Siemens Healthcare Diagnostics, Inc.2015-10-23
ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material (K143687)Siemens Healthcare Diagnostics, Inc.2015-07-17
MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) (K150039)Siemens Healthcare Diagnostics, Inc.2015-07-02
ADVIA Centaur TSH3-Ultra (K150403)Siemens Healthcare Diagnostics, Inc.2015-05-01
ADVIA CENTAUR TSH (K141999)Siemens Healthcare Diagnostics, Inc.2015-04-22
ADVIA Centaur Cortisol (COR) Assy (K142723)Siemens Healthcare Diagnostics, Inc.2015-03-31
IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material (K143373)Siemens Healthcare Diagnostics, Inc.2015-02-26
IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material (K143636)Siemens Healthcare Diagnostics, Inc.2015-02-25
ADVIA Centaur IgE Master Curve Material (K143680)Siemens Healthcare Diagnostics, Inc.2015-01-27
IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material (K143504)Siemens Healthcare Diagnostics, Inc.2015-01-14
IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material (K143352)Siemens Healthcare Diagnostics, Inc.2014-12-24
ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material (K143376)Siemens Healthcare Diagnostics, Inc.2014-12-23
ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) (K143194)Siemens Healthcare Diagnostics, Inc.2014-12-05
ADVIA Centaur HAV total assay (K142758)Siemens Healthcare Diagnostics, Inc.2014-12-05
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT (K140859)Siemens Healthcare Diagnostics, Inc.2014-11-26
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART (K140842)Siemens Healthcare Diagnostics, Inc.2014-11-26
IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material (K142878)Siemens Healthcare Diagnostics, Inc.2014-10-30
ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) (K142864)Siemens Healthcare Diagnostics, Inc.2014-10-29
IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM) (K142811)Siemens Healthcare Diagnostics, Inc.2014-10-29
IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL (K141772)Siemens Healthcare Diagnostics, Inc.2014-08-19
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA (K133156)Siemens Healthcare Diagnostics, Inc.2014-07-24
IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL (K141444)Siemens Healthcare Diagnostics, Inc.2014-07-09
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL (K133816)Siemens Healthcare Diagnostics, Inc.2014-06-24
IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY (K132801)Siemens Healthcare Diagnostics, Inc.2014-05-28
IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C (K140818)Siemens Healthcare Diagnostics, Inc.2014-05-01
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C (K140541)Siemens Healthcare Diagnostics, Inc.2014-04-01
ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL (K140505)Siemens Healthcare Diagnostics, Inc.2014-03-31
ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM) (K140267)Siemens Healthcare Diagnostics, Inc.2014-03-10
IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL (K140258)Siemens Healthcare Diagnostics, Inc.2014-03-05
ADVIA CENTAUR TESTOSTERONE (TSTO) (K133491)Siemens Healthcare Diagnostics, Inc.2014-02-21
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY (K133601)Siemens Healthcare Diagnostics, Inc.2014-02-05
DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE (K132638)Siemens Healthcare Diagnostics, Inc.2014-01-27
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