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
289–312 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 31, 2023
Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or...
K232310 · JWY
Thermo Fisher Scientific
Microbiology · 90d
Cleared Oct 27, 2023
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
K231214 · LFY
DiaSorin, Inc.
Microbiology · 182d
Cleared Oct 23, 2023
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2...
K232201 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Oct 19, 2023
Xpert Xpress MVP
K231381 · PQA
Cepheid
Microbiology · 160d
Cleared Oct 13, 2023
Xpert® Xpress CoV-2 plus
K230440 · QQX
Cepheid
Microbiology · 234d
Cleared Oct 10, 2023
ID NOW Influenza A & B 2
K232775 · OCC
Abbott Diagnostics Scarborough, Inc.
Microbiology · 29d
Cleared Oct 06, 2023
Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20
K232276 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 67d
Cleared Oct 05, 2023
ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
K232395 · JWY
Biom?rieux
Microbiology · 57d
Cleared Sep 29, 2023
DYNEX SmartPLEX MMRV IgG Assay Kit
K212769 · OPL
Dynex Technologies, Inc.
Microbiology · 759d
Cleared Sep 28, 2023
DNA/RNA Shield SafeCollect Saliva Collection kit
K231013 · QBD
Zymo Research
Microbiology · 171d
Cleared Sep 27, 2023
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
K222638 · NJR
Cepheid
Microbiology · 391d
Cleared Sep 20, 2023
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG...
K213987 · MXJ
Biokit, S.A.
Microbiology · 639d
Cleared Sep 15, 2023
T2 Biothreat Panel
K231336 · QVR
T2biosystems, Inc.
Microbiology · 130d
Cleared Aug 31, 2023
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution...
K231433 · NGZ
Thermo Fisher Scientific
Microbiology · 106d
Cleared Aug 31, 2023
BD Kiestra IdentifA
K222563 · QQV
Becton, Dickinson and Company
Microbiology · 372d
Cleared Aug 30, 2023
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K231988 · JWY
Thermo Fisher Scientific
Microbiology · 56d
Cleared Aug 25, 2023
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K231994 · JWY
Thermo Fisher Scientific
Microbiology · 51d
Cleared Aug 17, 2023
Xpert Xpress CoV-2/Flu/RSV plus
K231481 · QOF
Cepheid
Microbiology · 86d
Cleared Aug 10, 2023
HAVAb IgG II
K222850 · LOL
Abbott Laboratories
Microbiology · 323d
Cleared Aug 10, 2023
ID NOW COVID-19 2.0
K221925 · QWR
Abbott Diagnostics Scarborough, Inc.
Microbiology · 405d
Cleared Jul 31, 2023
BD Respiratory Viral Panel for BD MAX™ System
K230956 · QOF
Bd Integrated Diagnostic Solutions /
Microbiology · 118d
Cleared Jul 27, 2023
MDx-Chex for BC-GN
K231223 · PMN
Streck
Microbiology · 90d
Cleared Jul 27, 2023
MDx-Chex for BC-GP
K231221 · PMN
Streck
Microbiology · 90d
Cleared Jul 27, 2023
cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas®...
K223591 · QOF
Roche Molecular Systems, Inc.
Microbiology · 238d