Roche Diagnostics
Roche Diagnostics holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2026.
Clearances by Roche Diagnostics — page 2
101–184 of 184- K121679 — ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
- K112624 — ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
- K121895 — ELECSYS HSV-2 IGG IMMUNOASSAY
- K120625 — ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
- K113546 — ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
- K111353 — ACCU-CHECK COMBO SYSTEM
- K111188 — COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B
- K121279 — ELECSYS LH CALCHECK 5
- K113521 — CALCIUM GEN. 2
- K113137 — GLUCOSE TEST SYSTEM
- K110313 — TINA-QUANT HBA1C GEN.2
- K110726 — ROCHE ACETAMINOPHEN ASSAY
- K101299 — ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K112113 — ELECSYS MYOGLOBIN CALCHECK 5
- K112104 — ELECSYS N-MID OSTEOCALCIN CALCHECK 5
- K111552 — ELECSYS T3 CALCHECK 5
- K111506 — ELECSYS PRECICONTROL VARIA 3
- K111349 — ELECSYS SHBG CALCHECK 5
- K103716 — ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET
- K110613 — ELECSYS PROLACTIN II CALCHECK 5
- K110446 — ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID
- K093884 — ROCHE FLUDI METHAMPHETAMINE
- K093867 — ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A
- K101160 — ROCHE ORAL FLUID COCAINE
- K103171 — ELECSYS ANTI-TPO CALSET
- K093989 — ORAL FLUID PHENCYCLIDINE
- K102814 — ELECYSYS SHBG
- K103402 — ELECSYS DHEA-S CALCHECK 5
- K103221 — ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5
- K103099 — PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH
- K103162 — ELECSYS PTH CALCHECK 5
- K102086 — ELECSYS CA 125 II CALCHECK 5
- K102269 — ELECSYS IGE CALCHECK 5
- K101856 — ELECSYS CEA CALCHECK 5
- K101203 — TINA-QUANT ALBUMIN GEN 2
- K102267 — ELECSYS FERRITIN CALCHECK 5
- K101456 — ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
- K102016 — PRECICONTROL CLINCHEM MULTI 1 AND 2
- K102044 — ELECSYS DIGOXIN CALCHECK 5
- K102157 — ELECSYS PRECICONTROL MULTIMARKER
- K093955 — ANTI-HAV IGM
- K100538 — TINA-QUANT FERRITIN GEN. 4
- K094031 — ELECSYS FOLATE III CALCHECK 5
- K100810 — ELECSYS C-PEPTIDE CALCHECK 5
- K093836 — ELECSYS TSH CALCHECK 5
- K093555 — COBAS U411 TEST SYSTEM
- K100594 — ELECSYS TROPONIN I CALCHECK 5
- K093582 — ELECSYS CK-MB CALCHECK 5
- K091741 — TINA-QUANT CERULOPLASMIN
- K093460 — COAGUCHEK XS PRO SYSTEM
- K092322 — ELECSYS RUBELLA IGM IMMUNOASSAY
- K092169 — ELECSYS PROBNP II CALCHECK 5
- K092603 — COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
- K092168 — ELECSYS HCG+B CALCHECK 5
- K092320 — ELECSYS PRECICONTROL THYROAB
- K092585 — ELECSYS RUBELLA IGGA CALCHECK 5
- K083260 — ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
- K082699 — ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
- K090541 — ELECSYS PRECICONTROL UNIVERSAL
- K090939 — ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
- K090311 — ELECSYS RUBELLA IGG CALCHECK
- K083655 — ELECSYS TOXO IGG CALCHECK
- K081193 — COBAS INTEGRA 400/800 BILIRUBIN TOTAL
- K082595 — MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
- K081338 — ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP
- K080643 — ELECSYS ANTI-TSHR CALCHECK
- K081389 — ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K072437 — ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
- K070788 — ELECSYS CORTISOL TEST SYSTEM
- K071239 — TOTAL PROTEIN URINE/CSF GEN.3
- K071211 — COBAS C 111 ANALYZER
- K071041 — COAGUCHEK XS PLUS SYSTEM
- K063520 — ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS
- K061970 — ELECSYS IGE II IMMUNOASSAY
- K060978 — COAGUCHEK XS SYSTEM
- K060373 — COBAS 6000 SERIES SYSTEM
- K053059 — ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK
- K052982 — ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
- K052193 — ISE COMPENSATOR
- K052101 — C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
- K051376 — ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE
- K051752 — ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
- K050423 — OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
- K050026 — PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC
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