Roche Diagnostics - FDA 510(k) Cleared Devices
182
Total
180
Cleared
2
Denied
182 devices
Cleared
Oct 12, 2022
Elecsys CMV IgG
Microbiology
197d
Cleared
Oct 12, 2022
Elecsys HSV-1 IgG (08948844160)
Microbiology
195d
Cleared
Oct 12, 2022
Elecsys HSV-2 IgG (08948887160)
Microbiology
195d
Cleared
Sep 16, 2022
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2,...
Chemistry
241d
Cleared
Sep 15, 2022
Elecsys AFP
Immunology
237d
Cleared
Jun 10, 2022
Elecsys AMH
Chemistry
534d
Cleared
May 06, 2022
Elecsys Testosterone II
Chemistry
338d
Cleared
Mar 31, 2022
Elecsys proBNP II, Elecsys proBNP II STAT
Chemistry
399d
Cleared
Sep 21, 2021
Elecsys Troponin T Gen 5
Chemistry
477d
Cleared
Sep 01, 2021
Elecsys Vitamin D total III
Chemistry
159d
Cleared
Aug 18, 2021
Elecsys HCG STAT
Chemistry
289d
Cleared
Jul 20, 2021
Elecsys Syphilis
Microbiology
82d
Cleared
Nov 06, 2020
cobas u 701 microscopy analyzer
Hematology
224d
Cleared
Mar 09, 2020
Elecsys BRAHMS PCT
Microbiology
160d
Cleared
Feb 27, 2020
Elecsys Anti-TSHR
Immunology
90d
Cleared
Aug 16, 2019
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro...
Chemistry
31d
Cleared
Aug 13, 2019
Elecsys Anti-HAV II
Microbiology
172d
Cleared
May 07, 2019
cobas u 601 urinalysis test system
Chemistry
147d
Cleared
Apr 16, 2019
Elecsys TSH
Chemistry
21d
Cleared
Nov 06, 2018
Elecsys Tacrolimus
Toxicology
321d
Cleared
Sep 18, 2018
Elecsys FT4 III
Chemistry
132d
Cleared
Jul 06, 2018
Elecsys BRAHMS PCT
Microbiology
192d
Cleared
Jun 22, 2018
Elecsys CA 15-3 II
Immunology
16d
Cleared
Apr 19, 2018
CoaguChek XS Plus System
Hematology
35d
Cleared
Apr 19, 2018
CoaguChek XS Pro System
Hematology
34d
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