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Siemens Healthcare Diagnostics

92 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) (K243570)Siemens Healthcare Diagnostics2025-04-25
ADVIA 2120i, ADVIA 2120 (K162977)Siemens Healthcare Diagnostics2017-08-11
LOCI Total Vitamin D Total Assay, LOCI VITD CAL (K162298)Siemens Healthcare Diagnostics2017-03-16
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) (K161954)Siemens Healthcare Diagnostics2017-03-09
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator (K162538)Siemens Healthcare Diagnostics2016-11-17
Xprecia Stride Coagulation System, Xprecia System PT Controls (K151964)Siemens Healthcare Diagnostics2016-09-30
Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) (K150168)Siemens Healthcare Diagnostics2015-11-04
Dimension Vista MMB Assay (K143720)Siemens Healthcare Diagnostics2015-09-18
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) (K140790)Siemens Healthcare Diagnostics2015-06-15
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module (K150132)Siemens Healthcare Diagnostics2015-04-13
IMMULITE 2000 CEA Calibration Verification Material (K143639)Siemens Healthcare Diagnostics2015-01-23
CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT (K140717)Siemens Healthcare Diagnostics2014-11-17
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) (K133512)Siemens Healthcare Diagnostics2014-01-02
MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM (K122539)Siemens Healthcare Diagnostics2013-04-19
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL) (K130698)Siemens Healthcare Diagnostics2013-04-05
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY (K121981)Siemens Healthcare Diagnostics2013-03-21
DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) (K123677)Siemens Healthcare Diagnostics2013-03-07
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE (K123320)Siemens Healthcare Diagnostics2013-02-15
DIMENSION CHEMISTRY III CALIBRATORY (K123321)Siemens Healthcare Diagnostics2013-02-15
DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI (K122323)Siemens Healthcare Diagnostics2012-08-28
DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR (K121907)Siemens Healthcare Diagnostics2012-07-23
RAPIDPOINT 500 BLOOD GAS ANALYER (K113216)Siemens Healthcare Diagnostics2012-05-03
ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I (K102644)Siemens Healthcare Diagnostics2011-11-23
DIMENSION CLINICAL CHEMISTRY SYSTEM (K112999)Siemens Healthcare Diagnostics2011-11-22
DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE (K112142)Siemens Healthcare Diagnostics2011-11-04
CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL (K110061)Siemens Healthcare Diagnostics2011-09-21
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY (K110934)Siemens Healthcare Diagnostics2011-08-25
RAPIDPOINT 405 NEONATAL BILIRUBIN (K110277)Siemens Healthcare Diagnostics2011-08-15
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K101572)Siemens Healthcare Diagnostics2011-08-01
STRATUS CS ACUTE CARE D-DIMER (K110303)Siemens Healthcare Diagnostics2011-05-16
DIMENSIONS HB1C KIT, MODEL DF105A (K102510)Siemens Healthcare Diagnostics2011-05-13
IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) (K103683)Siemens Healthcare Diagnostics2011-04-28
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 (K100344)Siemens Healthcare Diagnostics2011-04-18
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 (K100321)Siemens Healthcare Diagnostics2011-04-12
DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H (K110169)Siemens Healthcare Diagnostics2011-04-07
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 (K101854)Siemens Healthcare Diagnostics2011-03-07
INNOVANCE D-DIMER, MODEL OPBP09 (K093626)Siemens Healthcare Diagnostics2010-11-29
ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL (K102904)Siemens Healthcare Diagnostics2010-11-23
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K093107)Siemens Healthcare Diagnostics2010-09-30
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES (K101425)Siemens Healthcare Diagnostics2010-09-10
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 (K100200)Siemens Healthcare Diagnostics2010-08-02
ADVIA 2120/2120I BODY FLUIDS (K090346)Siemens Healthcare Diagnostics2010-07-28
LOCI 8 CALIBRATOR, MODEL KC 646 (K101460)Siemens Healthcare Diagnostics2010-07-09
ADVIA CHEMISTRY SALICYLATE REAGENT (K093939)Siemens Healthcare Diagnostics2010-05-19
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, (K100433)Siemens Healthcare Diagnostics2010-05-13
ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 (K100289)Siemens Healthcare Diagnostics2010-05-10
DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A (K100778)Siemens Healthcare Diagnostics2010-05-05
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 (K093441)Siemens Healthcare Diagnostics2010-04-07
ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770 (K093732)Siemens Healthcare Diagnostics2010-03-22
EXL ANEM CAL, MODEL RC640 (K093645)Siemens Healthcare Diagnostics2010-03-05
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 (K093631)Siemens Healthcare Diagnostics2010-02-12
MICROSCAN MICROSTREP PLUS, MODEL B1027-201 (K091949)Siemens Healthcare Diagnostics2010-01-26
ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 (K091867)Siemens Healthcare Diagnostics2010-01-14
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM (K091361)Siemens Healthcare Diagnostics2009-12-16
ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL (K092993)Siemens Healthcare Diagnostics2009-11-20
INNOVANCE D-DIMER, MODEL OPBP09 (K091916)Siemens Healthcare Diagnostics2009-10-29
MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 (K092919)Siemens Healthcare Diagnostics2009-10-23
DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG (K092283)Siemens Healthcare Diagnostics2009-10-21
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 (K091216)Siemens Healthcare Diagnostics2009-10-09
ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS (K091123)Siemens Healthcare Diagnostics2009-08-14
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K091289)Siemens Healthcare Diagnostics2009-08-06
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 (K091264)Siemens Healthcare Diagnostics2009-07-22
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 (K090900)Siemens Healthcare Diagnostics2009-06-01
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 (K081769)Siemens Healthcare Diagnostics2009-05-28
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K090257)Siemens Healthcare Diagnostics2009-05-26
ADVIA CENTAUR TSH3-ULTRA METHOD (K083844)Siemens Healthcare Diagnostics2009-05-08
DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID (K090594)Siemens Healthcare Diagnostics2009-04-29
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 (K090236)Siemens Healthcare Diagnostics2009-04-27
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) (K083386)Siemens Healthcare Diagnostics2009-04-02
EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR (K083487)Siemens Healthcare Diagnostics2009-03-30
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC (K083445)Siemens Healthcare Diagnostics2009-03-24
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K083853)Siemens Healthcare Diagnostics2009-03-24
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M (K083463)Siemens Healthcare Diagnostics2009-03-13
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K083314)Siemens Healthcare Diagnostics2009-03-11
ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 (K083906)Siemens Healthcare Diagnostics2009-03-11
DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE (K083465)Siemens Healthcare Diagnostics2009-02-27
DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350 (K083462)Siemens Healthcare Diagnostics2009-02-27
DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 (K083579)Siemens Healthcare Diagnostics2009-02-20
MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML) (K083262)Siemens Healthcare Diagnostics2009-02-18
BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2 (K083175)Siemens Healthcare Diagnostics2009-01-26
BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2 (K083159)Siemens Healthcare Diagnostics2009-01-26
DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL (K082503)Siemens Healthcare Diagnostics2008-12-19
DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 (K071474)Siemens Healthcare Diagnostics2008-12-10
INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS (K081732)Siemens Healthcare Diagnostics2008-10-24
LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623 (K082680)Siemens Healthcare Diagnostics2008-10-10
DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 (K082645)Siemens Healthcare Diagnostics2008-09-22
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN (K081013)Siemens Healthcare Diagnostics2008-09-08
DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 (K081731)Siemens Healthcare Diagnostics2008-08-29
ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS (K080167)Siemens Healthcare Diagnostics2008-08-08
LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 (K081683)Siemens Healthcare Diagnostics2008-07-07
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 (K081643)Siemens Healthcare Diagnostics2008-07-03
DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE (K081300)Siemens Healthcare Diagnostics2008-07-02

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Every clearance here is in the API, with alerts when new ones post.