Medical Device Manufacturer · US , Indianapolos , IN

Roche Diagnostics - FDA 510(k) Cleared Devices

177 submissions · 175 cleared · Since 2005

Official Website

177

Total

175

Cleared

2

Denied

115 devices

26-50 of 115

Cleared Jan 23, 2017

Elecsys TSH assay, cobas e 801 Immunoassay analyzer

Chemistry · 126d

Cleared Jan 18, 2017

Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet,...

Chemistry · 93d

Not Cleared Dec 19, 2016

Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5

DEN150057 · PQO

Chemistry · 376d

Cleared Apr 27, 2016

Elecsys Cortisol II, Cortisol II CalSet

Chemistry · 264d

Cleared Apr 08, 2016

Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

Chemistry · 147d

Cleared Oct 02, 2015

Elecsys Progesterone III CalSet

Chemistry · 29d

Cleared Sep 24, 2015

Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet

Chemistry · 85d

Cleared May 01, 2015

Elecsys Progesterone III Cal Check 5

Chemistry · 22d

Cleared Mar 03, 2015

ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM

Chemistry · 236d

Cleared Dec 19, 2014

Elecsys T-Uptake Calset

Chemistry · 28d

Cleared Dec 16, 2014

Elecsys Estradiol III Calcheck

Chemistry · 29d

Cleared Oct 17, 2014

ELECSYS FOLATE III

Chemistry · 140d

Cleared Sep 05, 2014

ELECSYS ESTRADIOL III CALCHECK 5

Chemistry · 32d

Cleared Aug 29, 2014

ACCU-CHEK Performa Blood Glucose Monitoring System

Chemistry · 263d

Cleared Aug 12, 2014

Elecsys Estradiol III CalSet

Chemistry · 18d

Cleared Jul 17, 2014

COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR,...

Chemistry · 76d

Cleared May 22, 2014

ISE INDIRECT NA, K, C1 FOR GEN 2

Chemistry · 97d

Cleared May 08, 2014

ELECSYS CK-MB STAT IMMUNOASSAY

Chemistry · 79d

Cleared Mar 27, 2014

ELECSYS PRECICONTROL TS

Chemistry · 23d

Cleared Jan 27, 2014

ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET

Chemistry · 271d

Cleared Dec 18, 2013

COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2

Chemistry · 138d

Cleared Dec 04, 2013

ELECSYS CALCITONIN

Chemistry · 86d

Cleared Nov 26, 2013

C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM...

Chemistry · 25d

Cleared Nov 22, 2013

ELECSYS CK-MB CALCHECK 5

Chemistry · 28d

Cleared Oct 18, 2013

ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY

Chemistry · 64d

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