Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

491 results for "Roche Diagnostics"
1–24 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
Not Cleared Oct 20, 2026
Elecsys HBsAg II quant II RxDx
DEN260027 · SJM
Roche Diagnostics
Microbiology · 140d
Cleared Oct 02, 2026
Elecsys EBV IgM
K260233 · LJN
Roche Diagnostics
Microbiology · 249d
Cleared Oct 02, 2026
Elecsys EBV VCA IgG
K260232 · LSE
Roche Diagnostics
Microbiology · 249d
Cleared Oct 02, 2026
Elecsys EBV EBNA IgG
K260221 · LSE
Roche Diagnostics
Microbiology · 249d
Cleared Aug 19, 2026
Elecsys Phospho-Tau (217P) Plasma
K261686 · SET
Roche Diagnostics
Immunology · 90d
Cleared Jun 12, 2026
cobas pulse blood glucose monitoring system
K252323 · PZI
Roche Diagnostics
Chemistry · 322d
Cleared Apr 24, 2026
Elecsys Calcitonin
K252431 · JKR
Roche Diagnostics GmbH
Chemistry · 266d
Cleared Apr 13, 2026
Elecsys Anti-SARS-CoV-2 S
K252280 · QVP
Roche Diagnostics
Microbiology · 265d
Cleared Apr 07, 2026
Elecsys Anti-HBc IgM
K260049 · SEI
Roche Diagnostics
Microbiology · 90d
Cleared Apr 07, 2026
Elecsys Anti-HAV IgM
K260048 · LOL
Roche Diagnostics
Microbiology · 90d
Cleared Apr 07, 2026
Elecsys Anti-HBc II
K260046 · SEI
Roche Diagnostics
Microbiology · 90d
Cleared Apr 02, 2026
Tina-quant Cardiac high sensitivity CRP III
K260026 · NQD
Roche Diagnostics
Chemistry · 87d
Cleared Feb 12, 2026
ISE indirect K for Gen.2
K253491 · CEM
Roche Diagnostics
Chemistry · 111d
Cleared Feb 12, 2026
Glucose HK Gen.3
K253490 · CFR
Roche Diagnostics
Chemistry · 111d
Cleared Dec 17, 2025
Elecsys Anti-SARS-CoV-2
K253839 · QVP
Roche Diagnostics
Microbiology · 16d
Cleared Oct 24, 2025
CoaguChek XS Plus System
K253188 · GJS
Roche Diagnostics
Hematology · 28d
Cleared Oct 08, 2025
Elecsys Phospho-Tau (181P) Plasma
K252163 · SET
Roche Diagnostics
Immunology · 90d
Cleared Jul 17, 2025
Elecsys Cortisol III
K242505 · JFT
Roche Diagnostics
Chemistry · 329d
Cleared Jun 10, 2025
Elecsys Anti-SARS-CoV-2
K250768 · QVP
Roche Diagnostics
Microbiology · 89d
Cleared Feb 07, 2025
Elecsys sFlt-1 and Elecsys PlGF
K241453 · QWH
Roche Diagnostics
Chemistry · 261d
Cleared Jan 24, 2025
Tina-quant Lipoprotein(a) Gen.2 Molarity
K241220 · DFC
Roche Diagnostics Operations
Chemistry · 268d
Cleared Jun 17, 2024
Elecsys Folate III
K233060 · CGN
Roche Diagnostics
Chemistry · 266d
Cleared Apr 26, 2024
cobas pulse blood glucose monitoring system
K220272 · PZI
Roche Diagnostics
Chemistry · 816d
Cleared Mar 22, 2024
Elecsys PTH , Elecsys PTH STAT
K231927 · CEW
Roche Diagnostics
Chemistry · 266d