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Siemens Healthcare Diagnostics, Inc.

153 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE (K133728)Siemens Healthcare Diagnostics, Inc.2014-01-24
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR (K131307)Siemens Healthcare Diagnostics, Inc.2014-01-24
IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL (K132739)Siemens Healthcare Diagnostics, Inc.2014-01-14
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT (K133067)Siemens Healthcare Diagnostics, Inc.2013-11-22
IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM) (K133122)Siemens Healthcare Diagnostics, Inc.2013-10-30
IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA (K133124)Siemens Healthcare Diagnostics, Inc.2013-10-25
IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION (K133128)Siemens Healthcare Diagnostics, Inc.2013-10-22
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR (K132664)Siemens Healthcare Diagnostics, Inc.2013-10-16
IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL (K131662)Siemens Healthcare Diagnostics, Inc.2013-10-10
ADVIA CENTAUR FT4, ADVIA CENTAUR T4 (K132249)Siemens Healthcare Diagnostics, Inc.2013-09-13
IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL (K131536)Siemens Healthcare Diagnostics, Inc.2013-08-12
IMMULITE 2000 ANTI-CCP IGG ASSAY (K121576)Siemens Healthcare Diagnostics, Inc.2013-04-04
DIMENSION EXL WITH LM SYSTEM (K130276)Siemens Healthcare Diagnostics, Inc.2013-03-22
IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL (K122534)Siemens Healthcare Diagnostics, Inc.2013-03-14
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE (K123933)Siemens Healthcare Diagnostics, Inc.2013-03-14
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR (K123046)Siemens Healthcare Diagnostics, Inc.2012-12-20
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR (K121994)Siemens Healthcare Diagnostics, Inc.2012-11-30
RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS (K122398)Siemens Healthcare Diagnostics, Inc.2012-10-12
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR (K122599)Siemens Healthcare Diagnostics, Inc.2012-10-03
ADVIA CHEMISTRY GLUH_3 REAGENTS (K120681)Siemens Healthcare Diagnostics, Inc.2012-05-15
LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L (K121084)Siemens Healthcare Diagnostics, Inc.2012-05-09
ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR (K110874)Siemens Healthcare Diagnostics, Inc.2012-01-20
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS (K112343)Siemens Healthcare Diagnostics, Inc.2012-01-20
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K112523)Siemens Healthcare Diagnostics, Inc.2012-01-06
DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL (K113373)Siemens Healthcare Diagnostics, Inc.2011-12-30
ADVIA CENTAUR VITAMIN D TOTAL ASSAY (K110586)Siemens Healthcare Diagnostics, Inc.2011-10-14
ADVIA CHEMISTRY FERRITIN (FRT) METHOD (K110736)Siemens Healthcare Diagnostics, Inc.2011-08-17
MICROSCAN(R) MICROSTREP PLUS(R) (K111677)Siemens Healthcare Diagnostics, Inc.2011-08-04
MICROSCAN (R) MICROSTREP PLUS (R) PANELS (K111205)Siemens Healthcare Diagnostics, Inc.2011-07-20
MICROSCAN MICROSTEP (K111394)Siemens Healthcare Diagnostics, Inc.2011-06-22
ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 (K103548)Siemens Healthcare Diagnostics, Inc.2011-06-02
ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) (K102681)Siemens Healthcare Diagnostics, Inc.2011-05-04
DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 (K100375)Siemens Healthcare Diagnostics, Inc.2011-04-06
IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 (K093987)Siemens Healthcare Diagnostics, Inc.2011-03-28
EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C (K102779)Siemens Healthcare Diagnostics, Inc.2011-03-18
ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS (K103701)Siemens Healthcare Diagnostics, Inc.2011-02-18
ENZYME II CALIBRATOR (K103836)Siemens Healthcare Diagnostics, Inc.2011-02-16
DIMENSION VISA ENZ 2 CAL (K103612)Siemens Healthcare Diagnostics, Inc.2011-01-25
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 (K090330)Siemens Healthcare Diagnostics, Inc.2009-05-22
DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) (K083339)Siemens Healthcare Diagnostics, Inc.2009-03-09
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL (K082638)Siemens Healthcare Diagnostics, Inc.2009-02-26
IMMULITE 2000 FREE T4 (K083373)Siemens Healthcare Diagnostics, Inc.2009-02-02
DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 (K081857)Siemens Healthcare Diagnostics, Inc.2008-10-30
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR (K081789)Siemens Healthcare Diagnostics, Inc.2008-09-10
DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 (K082030)Siemens Healthcare Diagnostics, Inc.2008-08-22
DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA (K081299)Siemens Healthcare Diagnostics, Inc.2008-08-08
DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 (K081992)Siemens Healthcare Diagnostics, Inc.2008-08-05
DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56 (K081319)Siemens Healthcare Diagnostics, Inc.2008-08-04
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS (K081294)Siemens Healthcare Diagnostics, Inc.2008-07-29
ADVIA CENTAUR HAVM ASSAY (K081716)Siemens Healthcare Diagnostics, Inc.2008-07-17
DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 (K081074)Siemens Healthcare Diagnostics, Inc.2008-05-23
LOCI THYROID CALIBRATOR WITH MODEL RC610 (K081103)Siemens Healthcare Diagnostics, Inc.2008-05-23
DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA (K080578)Siemens Healthcare Diagnostics, Inc.2008-05-16
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Every clearance here is in the API, with alerts when new ones post.