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Roche Diagnostics

183 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
cobas pulse blood glucose monitoring system (K252323)Roche Diagnostics2026-06-12
Elecsys Anti-SARS-CoV-2 S (K252280)Roche Diagnostics2026-04-13
Elecsys Anti-HBc IgM (K260049)Roche Diagnostics2026-04-07
Elecsys Anti-HBc II (K260046)Roche Diagnostics2026-04-07
Elecsys Anti-HAV IgM (K260048)Roche Diagnostics2026-04-07
Tina-quant Cardiac high sensitivity CRP III (K260026)Roche Diagnostics2026-04-02
Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (K253490)Roche Diagnostics2026-02-12
ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions (K253491)Roche Diagnostics2026-02-12
Elecsys Anti-SARS-CoV-2 (K253839)Roche Diagnostics2025-12-17
CoaguChek XS Plus System (K253188)Roche Diagnostics2025-10-24
Elecsys Phospho-Tau (181P) Plasma (K252163)Roche Diagnostics2025-10-08
Elecsys Cortisol III (K242505)Roche Diagnostics2025-07-17
Elecsys Anti-SARS-CoV-2 (K250768)Roche Diagnostics2025-06-10
Elecsys sFlt-1 and Elecsys PlGF (K241453)Roche Diagnostics2025-02-07
Elecsys Folate III (K233060)Roche Diagnostics2024-06-17
cobas pulse blood glucose monitoring system (K220272)Roche Diagnostics2024-04-26
Elecsys PTH , Elecsys PTH STAT (K231927)Roche Diagnostics2024-03-22
Elecsys Tg II (K221890)Roche Diagnostics2023-09-30
Elecsys Anti-Tg (K222610)Roche Diagnostics2023-09-15
Elecsys proBNP II, Elecsys proBNP II STAT (K223637)Roche Diagnostics2023-07-21
Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF (K231348)Roche Diagnostics2023-06-05
Elecsys FT4 IV (K220456)Roche Diagnostics2023-04-07
ONLINE TDM Phenytoin - Free Phenytoin application (K230161)Roche Diagnostics2023-03-30
Elecsys Anti-HCV II (08837031190) (K221693)Roche Diagnostics2023-01-04
ONLINE DAT Benzodiazepines II (K221765)Roche Diagnostics2022-12-23
Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF (K221842)Roche Diagnostics2022-12-07
Elecsys CMV IgG (K220911)Roche Diagnostics2022-10-12
Elecsys HSV-2 IgG (08948887160) (K220924)Roche Diagnostics2022-10-12
Elecsys HSV-1 IgG (08948844160) (K220923)Roche Diagnostics2022-10-12
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH (K220134)Roche Diagnostics2022-09-16
Elecsys AFP (K220176)Roche Diagnostics2022-09-15
Elecsys AMH (K203757)Roche Diagnostics2022-06-10
Elecsys Testosterone II (K211685)Roche Diagnostics2022-05-06
Elecsys proBNP II, Elecsys proBNP II STAT (K210546)Roche Diagnostics2022-03-31
Elecsys Troponin T Gen 5 (K201441)Roche Diagnostics2021-09-21
Elecsys Vitamin D total III (K210901)Roche Diagnostics2021-09-01
Elecsys HCG STAT (K203227)Roche Diagnostics2021-08-18
Elecsys Syphilis (K211302)Roche Diagnostics2021-07-20
cobas u 701 microscopy analyzer (K200811)Roche Diagnostics2020-11-06
Elecsys BRAHMS PCT (K192815)Roche Diagnostics2020-03-09
Elecsys Anti-TSHR (K193313)Roche Diagnostics2020-02-27
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions (K191899)Roche Diagnostics2019-08-16
Elecsys Anti-HAV II (K190428)Roche Diagnostics2019-08-13
cobas u 601 urinalysis test system (K183432)Roche Diagnostics2019-05-07
Elecsys TSH (K190773)Roche Diagnostics2019-04-16
Elecsys Tacrolimus (K173857)Roche Diagnostics2018-11-06
Elecsys FT4 III (K181233)Roche Diagnostics2018-09-18
Elecsys BRAHMS PCT (K173927)Roche Diagnostics2018-07-06
Elecsys CA 15-3 II (K181492)Roche Diagnostics2018-06-22
CoaguChek XS Plus System (K180684)Roche Diagnostics2018-04-19
CoaguChek XS Pro System (K180693)Roche Diagnostics2018-04-19
Elecsys CA 15-3 II (K171605)Roche Diagnostics2018-02-20
CoaguChek Vantus System (K170960)Roche Diagnostics2017-12-25
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl (K162678)Roche Diagnostics2017-06-23
Creatine Kinase-MB (K162526)Roche Diagnostics2017-05-26
CalSet IGF-1 (K170938)Roche Diagnostics2017-04-26
Beta-CrossLaps CalCheck 5 (K170678)Roche Diagnostics2017-04-04
Elecsys CMV IgM (K163569)Roche Diagnostics2017-03-17
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 (K162840)Roche Diagnostics2017-02-08
Elecsys TSH assay, cobas e 801 Immunoassay analyzer (K162606)Roche Diagnostics2017-01-23
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 (K162895)Roche Diagnostics2017-01-18
Elecsys CYFRA 21-1 CalCheck 5 (K162173)Roche Diagnostics2017-01-12
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 (DEN150057)Roche Diagnostics2016-12-19
Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker (K160915)Roche Diagnostics2016-12-14
Elecsys Syphilis (K160910)Roche Diagnostics2016-07-28
ROMA Calculation Tool Using Elecsys Assays (K153607)Roche Diagnostics2016-06-15
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 (K160729)Roche Diagnostics2016-06-13
Elecsys Cortisol II, Cortisol II CalSet (K152227)Roche Diagnostics2016-04-27
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II (K153301)Roche Diagnostics2016-04-08
Elecsys Progesterone III CalSet (K152526)Roche Diagnostics2015-10-02
Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet (K151786)Roche Diagnostics2015-09-24
Elecsys Progesterone III Cal Check 5 (K150955)Roche Diagnostics2015-05-01
ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM (K141867)Roche Diagnostics2015-03-03
Elecsys T-Uptake Calset (K143342)Roche Diagnostics2014-12-19
Elecsys Estradiol III Calcheck (K143284)Roche Diagnostics2014-12-16
ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM (K142133)Roche Diagnostics2014-10-24
ELECSYS FOLATE III (K141426)Roche Diagnostics2014-10-17
ELECSYS ESTRADIOL III CALCHECK 5 (K142127)Roche Diagnostics2014-09-05
ACCU-CHEK Performa Blood Glucose Monitoring System (K133741)Roche Diagnostics2014-08-29
Elecsys Estradiol III CalSet (K142021)Roche Diagnostics2014-08-12
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET (K141143)Roche Diagnostics2014-07-17
CA 125 II CALSET II (K140112)Roche Diagnostics2014-06-06
ISE INDIRECT NA, K, C1 FOR GEN 2 (K140373)Roche Diagnostics2014-05-22
ELECSYS CK-MB STAT IMMUNOASSAY (K140404)Roche Diagnostics2014-05-08
ELECSYS PRECICONTROL TS (K140534)Roche Diagnostics2014-03-27
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY (K131605)Roche Diagnostics2014-02-28
ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET (K131244)Roche Diagnostics2014-01-27
COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 (K132418)Roche Diagnostics2013-12-18
ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3 (K132828)Roche Diagnostics2013-12-04
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN (K133330)Roche Diagnostics2013-11-26
ELECSYS CK-MB CALCHECK 5 (K133284)Roche Diagnostics2013-11-22
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY (K132571)Roche Diagnostics2013-10-18
COBAS C BILIRUBIN TOTAL GEN.3 (K131544)Roche Diagnostics2013-07-17
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM (DEN130002)Roche Diagnostics2013-05-23
COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 (K123726)Roche Diagnostics2013-05-21
COBAS INTEGRA BILIRUBIN DIRECT GEN.2 (K123965)Roche Diagnostics2013-02-28
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM (K113614)Roche Diagnostics2013-02-12
ELECSYS CA 15-3 II CALCHECK 5 (K122242)Roche Diagnostics2012-12-05
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 (K122722)Roche Diagnostics2012-11-29
ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM (K121679)Roche Diagnostics2012-10-11
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