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

Filters: Microbiology ×
7,095 results
481–504 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 09, 2021
cobas Cdiff nucleic acid test for use on the cobas Liat System
K210385 · OZN
Roche Molecular Systems, Inc.
Microbiology · 212d
Cleared Sep 01, 2021
MeMed BV
K210254 · QPS
MeMed Diagnostics, Ltd.
Microbiology · 215d
Cleared Aug 30, 2021
VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
K211630 · LON
bioMerieux, Inc.
Microbiology · 95d
Cleared CT Aug 26, 2021
Visby Medical Sexual Health
K200748 · QEP
Visby Medical
Microbiology · 521d
Cleared Aug 11, 2021
Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha...
K212204 · QGN
Cd Diagnostics, Inc.
Microbiology · 27d
Cleared Jul 30, 2021
Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
K203700 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 224d
Cleared Jul 23, 2021
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or...
K202612 · JWY
Thermo Fisher Scientific
Microbiology · 317d
Cleared Jul 20, 2021
Elecsys Syphilis
K211302 · LIP
Roche Diagnostics
Microbiology · 82d
Cleared Jul 09, 2021
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
K201675 · LON
bioMerieux, Inc.
Microbiology · 385d
Cleared Jul 08, 2021
SensiTox C. difficile Toxin Test
K193490 · LLH
First Light Diagnostics, Inc.
Microbiology · 569d
Cleared Jun 24, 2021
BioFire RP2.1/RP2.1plus Control Panel M441
K202196 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 323d
Cleared Jun 14, 2021
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
K211136 · LON
bioMerieux, Inc.
Microbiology · 59d
Cleared May 18, 2021
MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
K202423 · JWY
Beckman Coulter, Inc.
Microbiology · 266d
Cleared Mar 22, 2021
Capture-CMV
K203612 · LJO
Immucor, Inc.
Microbiology · 102d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
K203296 · LSR
Gold Standard Diagnostics
Microbiology · 133d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
K203295 · LSR
Gold Standard Diagnostics
Microbiology · 133d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
K203292 · LSR
Gold Standard Diagnostics
Microbiology · 133d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
K203289 · LSR
Gold Standard Diagnostics
Microbiology · 133d
Not Cleared Mar 17, 2021
BioFire Respiratory Panel 2.1 (RP2.1)
DEN200031 · QOF
Biofire Diagnostics, LLC
Microbiology · 302d
Cleared Mar 03, 2021
Cultura Collection and Transport System
K201674 · JSM
Merit Medical Systems, Inc.
Microbiology · 257d
Cleared Feb 18, 2021
LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
K202574 · LSR
DiaSorin, Inc.
Microbiology · 167d
Cleared Feb 18, 2021
LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
K202573 · LSR
DiaSorin, Inc.
Microbiology · 167d
Cleared Feb 16, 2021
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
K210234 · OCC
Roche Molecular Systems, Inc.
Microbiology · 19d
Cleared Feb 09, 2021
LIAISON Anti-HAV
K210272 · LOL
DiaSorin, Inc.
Microbiology · 8d