FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,061 results
625–648 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Not Cleared Sep 21, 2018
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
DEN070001 · PBK
Centers For Disease Control and...
Microbiology · 4266d
Cleared Sep 20, 2018
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K181205 · PBK
Centers For Disease Control and...
Microbiology · 136d
Cleared Sep 18, 2018
BioSign Flu A+B
K182157 · PSZ
Princeton BioMeditech Corp.
Microbiology · 40d
Cleared Sep 13, 2018
MTS Penicillin 0.002- 32 µg/mL
K181889 · JWY
Liofilchem S. R. L.
Microbiology · 62d
Cleared Aug 31, 2018
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
K181464 · LYR
DiaSorin, Inc.
Microbiology · 88d
Cleared Aug 30, 2018
Sofia 2 Lyme FIA, Sofia Lyme Control Set
K173496 · LSR
Quidel Corporation
Microbiology · 290d