FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
457–480 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Jan 29, 2021
cobas BKV
K203220 · QLX
Roche Molecular Systems, Inc.
Microbiology · 88d
Cleared Jan 21, 2021
cobas CTNG for use on cobas 6800/8800 systems
K202408 · QEP
Roche Molecular Systems, Inc.
Microbiology · 153d
Cleared Dec 27, 2020
MBT Sepsityper
K193419 · QNJ
Bruker Daltonik GmbH
Microbiology · 384d
Cleared Dec 14, 2020
DNA/RNA Shield Collection Tube
K202641 · QBD
Zymo Research
Microbiology · 94d