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"
25–48 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
Cleared Feb 20, 2024
ONLINE TDM Methotrexate
K233454 · LAO
Roche Diagnostics Operations
Toxicology · 123d
Cleared Sep 30, 2023
Elecsys Tg II
K221890 · MSW
Roche Diagnostics
Immunology · 458d
Cleared Sep 15, 2023
Elecsys Anti-Tg
K222610 · JZO
Roche Diagnostics
Immunology · 382d
Cleared Jul 21, 2023
Elecsys proBNP II, Elecsys proBNP II STAT
K223637 · NBC
Roche Diagnostics
Chemistry · 228d
Cleared Jun 05, 2023
Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
K231348 · QSE
Roche Diagnostics
Immunology · 27d
Cleared Apr 07, 2023
Elecsys FT4 IV
K220456 · CEC
Roche Diagnostics
Chemistry · 414d
Cleared Mar 30, 2023
ONLINE TDM Phenytoin - Free Phenytoin application
K230161 · MOJ
Roche Diagnostics
Chemistry · 69d
Cleared Jan 04, 2023
Elecsys Anti-HCV II (08837031190)
K221693 · MZO
Roche Diagnostics
Microbiology · 208d
Cleared Dec 23, 2022
ONLINE DAT Benzodiazepines II
K221765 · JXM
Roche Diagnostics
Toxicology · 189d
Cleared Dec 07, 2022
Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
K221842 · QSE
Roche Diagnostics
Immunology · 166d
Cleared Oct 12, 2022
Elecsys HSV-2 IgG (08948887160)
K220924 · MYF
Roche Diagnostics
Microbiology · 195d
Cleared Oct 12, 2022
Elecsys HSV-1 IgG (08948844160)
K220923 · MXJ
Roche Diagnostics
Microbiology · 195d
Cleared Oct 12, 2022
Elecsys CMV IgG
K220911 · LFZ
Roche Diagnostics
Microbiology · 197d
Cleared Sep 16, 2022
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2,...
K220134 · CFR
Roche Diagnostics
Chemistry · 241d
Cleared Sep 15, 2022
Elecsys AFP
K220176 · LOJ
Roche Diagnostics
Immunology · 237d
Cleared Jun 10, 2022
Elecsys AMH
K203757 · PQO
Roche Diagnostics
Chemistry · 534d
Cleared May 06, 2022
Elecsys Testosterone II
K211685 · CDZ
Roche Diagnostics
Chemistry · 338d
Cleared Mar 31, 2022
Elecsys proBNP II, Elecsys proBNP II STAT
K210546 · NBC
Roche Diagnostics
Chemistry · 399d
Cleared Sep 21, 2021
Elecsys Troponin T Gen 5
K201441 · MMI
Roche Diagnostics
Chemistry · 477d
Cleared Sep 01, 2021
Elecsys Vitamin D total III
K210901 · MRG
Roche Diagnostics
Chemistry · 159d
Cleared Aug 18, 2021
Elecsys HCG STAT
K203227 · DHA
Roche Diagnostics
Chemistry · 289d
Cleared Jul 20, 2021
Elecsys Syphilis
K211302 · LIP
Roche Diagnostics
Microbiology · 82d
Cleared Nov 06, 2020
cobas u 701 microscopy analyzer
K200811 · LKM
Roche Diagnostics
Hematology · 224d
Cleared Mar 26, 2020
Tina-quant Hemoglobin A1cDx Gen.3
K193053 · PDJ
Roche Diagnostics Operations (Rdo)
Chemistry · 146d