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
625–648 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 20, 2018
MTS Levofloxacin 0.002 - 32 µg/mL
K183115 · JWY
Liofilchem S. R. L.
Microbiology · 41d
Cleared Dec 20, 2018
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
K181663 · PAM
Genmark Diagnostics, Incorporated
Microbiology · 178d
Cleared Dec 19, 2018
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
K183223 · OZZ
Diasorin Molecular, LLC
Microbiology · 29d
Cleared Dec 17, 2018
Acucy Influenza A&B Test with the Acucy System
K182001 · PSZ
SEKISUI Diagnostics, LLC
Microbiology · 144d
Cleared Dec 14, 2018
MTS Omadacycline 0.002-32 µg/mL
K182922 · JWY
Liofilchem S. R. L.
Microbiology · 56d
Cleared Dec 10, 2018
VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance
K181766 · LON
bioMerieux, Inc.
Microbiology · 160d
Cleared Nov 30, 2018
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS...
K183030 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 29d
Cleared Nov 30, 2018
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS...
K183023 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 29d
Cleared Nov 30, 2018
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K182797 · JWY
Thermo Fisher Scientific
Microbiology · 60d
Cleared Nov 30, 2018
ASI Automated ASI RPR Test for Syphilis on the ASI Evolution
K182391 · GMQ
Arlington Scientific, Inc. (Asi)
Microbiology · 87d
Not Cleared Nov 30, 2018
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
DEN180040 · QDZ
Meridian Bioscience, Inc.
Microbiology · 123d
Cleared Nov 29, 2018
BD MAX Enteric Viral Panel, BD MAX Instrument
K181427 · PCH
Becton, Dickinson and Company
Microbiology · 181d
Cleared Nov 23, 2018
Accula RSV Test
K181443 · OCC
Mesa Biotech, Inc.
Microbiology · 176d
Cleared Nov 15, 2018
FilmArray Pneumonia Panel plus
K181324 · QDS
Biofire Diagnostics, LLC
Microbiology · 181d
Cleared Nov 09, 2018
FilmArray Pneumonia Panel
K180966 · QDP
Biofire Diagnostics, LLC
Microbiology · 210d
Cleared Nov 08, 2018
Cepheid Xpert GBS LB Control Panel
K182472 · PMN
Microbiologics, Inc.
Microbiology · 59d
Cleared Nov 07, 2018
Simplexa GBS Direct, Simplexa GBS Positive Control Pack
K182467 · NJR
Diasorin Molecular, LLC
Microbiology · 58d
Cleared Nov 05, 2018
PREMIER Platinum HpSA PLUS
K182559 · LYR
Meridian Bioscience, Inc.
Microbiology · 49d
Cleared Nov 02, 2018
MTS Eravacycline 0.002 - 32 µg/mL
K182557 · JWY
Liofilchem S. R. L.
Microbiology · 46d
Cleared Oct 29, 2018
HSV 1 & 2 ELITe MGB Kit
K180559 · PGI
Elitechgroup
Microbiology · 242d
Cleared Sep 28, 2018
BioCode Gastrointestinal Pathogen Panel (GPP)
K180041 · PCH
Applied BioCode, Inc.
Microbiology · 266d
Cleared Sep 27, 2018
Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30
K181975 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 65d
Cleared Sep 26, 2018
HardyDisk AST Eravacycline 20µg (ERV20)
K182357 · JTN
Hardy Diagnostics
Microbiology · 27d
Cleared Sep 21, 2018
BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN
K181665 · LON
Becton, Dickinson and Company
Microbiology · 88d