Roche Diagnostics - FDA 510(k) Cleared Devices
188
Total
185
Cleared
3
Denied
188 devices
Cleared
Jun 05, 2023
Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
Immunology
27d
Cleared
Apr 07, 2023
Elecsys FT4 IV
Chemistry
414d
Cleared
Mar 30, 2023
ONLINE TDM Phenytoin - Free Phenytoin application
Chemistry
69d
Cleared
Jan 04, 2023
Elecsys Anti-HCV II (08837031190)
Microbiology
208d
Cleared
Dec 23, 2022
ONLINE DAT Benzodiazepines II
Toxicology
189d
Cleared
Dec 07, 2022
Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
Immunology
166d
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
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