Roche Diagnostics
Roche Diagnostics holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2026.
Top product codes for Roche Diagnostics
Recent clearances by Roche Diagnostics
1–100 of 184- K261686 — Elecsys Phospho-Tau (217P) Plasma
- K252323 — cobas pulse blood glucose monitoring system
- K252280 — Elecsys Anti-SARS-CoV-2 S
- K260046 — Elecsys Anti-HBc II
- K260048 — Elecsys Anti-HAV IgM
- K260049 — Elecsys Anti-HBc IgM
- K260026 — Tina-quant Cardiac high sensitivity CRP III
- K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions
- K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions
- K253839 — Elecsys Anti-SARS-CoV-2
- K253188 — CoaguChek XS Plus System
- K252163 — Elecsys Phospho-Tau (181P) Plasma
- K242505 — Elecsys Cortisol III
- K250768 — Elecsys Anti-SARS-CoV-2
- K241453 — Elecsys sFlt-1 and Elecsys PlGF
- K233060 — Elecsys Folate III
- K220272 — cobas pulse blood glucose monitoring system
- K231927 — Elecsys PTH , Elecsys PTH STAT
- K221890 — Elecsys Tg II
- K222610 — Elecsys Anti-Tg
- K223637 — Elecsys proBNP II, Elecsys proBNP II STAT
- K231348 — Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
- K220456 — Elecsys FT4 IV
- K230161 — ONLINE TDM Phenytoin - Free Phenytoin application
- K221693 — Elecsys Anti-HCV II (08837031190)
- K221765 — ONLINE DAT Benzodiazepines II
- K221842 — Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
- K220911 — Elecsys CMV IgG
- K220923 — Elecsys HSV-1 IgG (08948844160)
- K220924 — Elecsys HSV-2 IgG (08948887160)
- K220134 — cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
- K220176 — Elecsys AFP
- K203757 — Elecsys AMH
- K211685 — Elecsys Testosterone II
- K210546 — Elecsys proBNP II, Elecsys proBNP II STAT
- K201441 — Elecsys Troponin T Gen 5
- K210901 — Elecsys Vitamin D total III
- K203227 — Elecsys HCG STAT
- K211302 — Elecsys Syphilis
- K200811 — cobas u 701 microscopy analyzer
- K192815 — Elecsys BRAHMS PCT
- K193313 — Elecsys Anti-TSHR
- K191899 — Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
- K190428 — Elecsys Anti-HAV II
- K183432 — cobas u 601 urinalysis test system
- K190773 — Elecsys TSH
- K173857 — Elecsys Tacrolimus
- K181233 — Elecsys FT4 III
- K173927 — Elecsys BRAHMS PCT
- K181492 — Elecsys CA 15-3 II
- K180684 — CoaguChek XS Plus System
- K180693 — CoaguChek XS Pro System
- K171605 — Elecsys CA 15-3 II
- K170960 — CoaguChek Vantus System
- K162678 — Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
- K162526 — Creatine Kinase-MB
- K170938 — CalSet IGF-1
- K170678 — Beta-CrossLaps CalCheck 5
- K163569 — Elecsys CMV IgM
- K162840 — Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5
- K162606 — Elecsys TSH assay, cobas e 801 Immunoassay analyzer
- K162895 — Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5
- K162173 — Elecsys CYFRA 21-1 CalCheck 5
- DEN150057 — Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
- K160915 — Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
- K160910 — Elecsys Syphilis
- K153607 — ROMA Calculation Tool Using Elecsys Assays
- K160729 — Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
- K152227 — Elecsys Cortisol II, Cortisol II CalSet
- K153301 — Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
- K152526 — Elecsys Progesterone III CalSet
- K151786 — Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
- K150955 — Elecsys Progesterone III Cal Check 5
- K141867 — ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
- K143342 — Elecsys T-Uptake Calset
- K143284 — Elecsys Estradiol III Calcheck
- K142133 — ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM
- K141426 — ELECSYS FOLATE III
- K142127 — ELECSYS ESTRADIOL III CALCHECK 5
- K133741 — ACCU-CHEK Performa Blood Glucose Monitoring System
- K142021 — Elecsys Estradiol III CalSet
- K141143 — COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
- K140112 — CA 125 II CALSET II
- K140373 — ISE INDIRECT NA, K, C1 FOR GEN 2
- K140404 — ELECSYS CK-MB STAT IMMUNOASSAY
- K140534 — ELECSYS PRECICONTROL TS
- K131605 — ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
- K131244 — ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET
- K132418 — COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
- K132828 — ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3
- K133330 — C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
- K133284 — ELECSYS CK-MB CALCHECK 5
- K132571 — ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
- K131544 — COBAS C BILIRUBIN TOTAL GEN.3
- DEN130002 — TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
- K123726 — COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
- K123965 — COBAS INTEGRA BILIRUBIN DIRECT GEN.2
- K113614 — ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K122242 — ELECSYS CA 15-3 II CALCHECK 5
- K122722 — COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
Data sourced from openFDA. This site is unofficial and independent of the FDA.