Roche Diagnostics - FDA 510(k) Cleared Devices
182
Total
180
Cleared
2
Denied
182 devices
Cleared
Feb 20, 2018
Elecsys CA 15-3 II
Immunology
264d
Cleared
Dec 25, 2017
CoaguChek Vantus System
Hematology
269d
Cleared
Jun 23, 2017
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
Microbiology
270d
Cleared
May 26, 2017
Creatine Kinase-MB
Chemistry
259d
Cleared
Apr 26, 2017
CalSet IGF-1
Chemistry
27d
Cleared
Apr 04, 2017
Beta-CrossLaps CalCheck 5
Chemistry
29d
Cleared
Mar 17, 2017
Elecsys CMV IgM
Microbiology
88d
Cleared
Feb 08, 2017
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D...
Chemistry
120d
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
Cleared
Jan 12, 2017
Elecsys CYFRA 21-1 CalCheck 5
Immunology
162d
Not Cleared
Dec 19, 2016
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
Chemistry
376d
Cleared
Dec 14, 2016
Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
Immunology
257d
Cleared
Jul 28, 2016
Elecsys Syphilis
Microbiology
118d
Cleared
Jun 15, 2016
ROMA Calculation Tool Using Elecsys Assays
Immunology
181d
Cleared
Jun 13, 2016
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
Microbiology
89d
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 24, 2014
ELECYS CMV IGM IMMUNOASSAY
Microbiology
81d
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