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
577–600 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Not Cleared May 23, 2019
Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin...
DEN180032 · QGN
Cd Diagnostics, Inc.
Microbiology · 328d
Cleared May 22, 2019
cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control...
K190433 · QEP
Roche Molecular Systems, Inc.
Microbiology · 89d
Cleared May 18, 2019
QIAstat-Dx Respiratory Panel
K183597 · OCC
QIAGEN GmbH
Microbiology · 148d
Cleared May 16, 2019
Aptima CV/TV Assay
K190472 · PQA
Hologic, Inc.
Microbiology · 79d
Cleared May 15, 2019
BACT/ALERT MP Reagent System
K190405 · MDB
bioMerieux, Inc.
Microbiology · 85d
Cleared May 15, 2019
APAS Independence with Urine Analysis Module
K183648 · PPU
Clever Culture Systems AG
Microbiology · 140d
Cleared May 13, 2019
Simplexa VZV Direct, Simplexa VZV Positive Control Pack
K190219 · PLO
Diasorin Molecular, LLC
Microbiology · 98d
Cleared May 10, 2019
GenePOC Carba
K190275 · PMY
Genepoc, Inc.
Microbiology · 91d
Cleared May 08, 2019
Cepheid Xpert CT/NG Control Panel
K190223 · PMN
Microbiologics, Inc.
Microbiology · 92d
Cleared May 03, 2019
FilmArray Pneumonia/Pneumoniaplus Control
K190222 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 87d
Cleared May 01, 2019
ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
K190154 · JWY
Biomerieux S.A.
Microbiology · 91d
Cleared Apr 29, 2019
HardyCHROM CRE
K190553 · JSO
Hardy Diagnostics
Microbiology · 55d
Cleared Apr 25, 2019
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s...
K190771 · NQX
Cepheid
Microbiology · 30d
Cleared Apr 22, 2019
FluChip-8G Influenza A+B Assay
K182513 · OZE
Indevr, Inc.
Microbiology · 222d
Cleared Apr 19, 2019
Cepheid Xpert C. difficile/Epi Control Panel
K190463 · PMN
Microbiologics, Inc.
Microbiology · 52d
Cleared Apr 18, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV)...
K190109 · JWY
Beckman Coulter, Inc.
Microbiology · 85d
Cleared Apr 12, 2019
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
K182619 · PEN
Genmark Diagnostics, Incorporated
Microbiology · 200d
Cleared Mar 27, 2019
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B...
K190302 · OZE
Centers For Disease Control and...
Microbiology · 43d
Cleared Mar 22, 2019
MTS Gentamicin 0.016 - 256 µg/mL
K190252 · JWY
Liofilchem S. R. L.
Microbiology · 43d
Cleared Mar 19, 2019
MTS Ciprofloxacin 0.002 - 32 µg/mL
K183527 · JWY
Liofilchem S. R. L.
Microbiology · 90d
Cleared Mar 18, 2019
ID NOW Influenza A & B 2
K190204 · OZE
Alere Scarborough, Inc.
Microbiology · 42d
Cleared Mar 18, 2019
Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
K181599 · QFS
Beckman Coulter
Microbiology · 273d
Cleared Mar 14, 2019
Vstrip H. pylori Antigen Rapid Test
K183573 · LYR
Panion & BF Biotech, Inc.
Microbiology · 83d
Cleared Mar 12, 2019
VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
K183524 · LON
bioMerieux, Inc.
Microbiology · 83d