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
817–840 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jan 12, 2017
VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
K161217 · LON
bioMerieux, Inc.
Microbiology · 258d
Cleared Jan 06, 2017
LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set
K162969 · LFZ
DiaSorin, Inc.
Microbiology · 74d
Cleared Jan 05, 2017
LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set
K162961 · LSE
DiaSorin, Inc.
Microbiology · 73d
Cleared Jan 04, 2017
LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
K162959 · LSE
DiaSorin, Inc.
Microbiology · 72d
Cleared Dec 23, 2016
ARIES GBS Assay
K162772 · NJR
Luminex Corporation
Microbiology · 81d
Cleared Dec 21, 2016
Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i...
K163266 · OCC
Alere Scarborough, Inc.
Microbiology · 30d
Cleared Dec 19, 2016
Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml
K162854 · JWY
Liofilchem S. R. L.
Microbiology · 68d
Cleared Dec 16, 2016
Chagas Detect Plus Rapid Test
K161947 · MIU
InBios International, Inc.
Microbiology · 155d
Cleared Nov 28, 2016
Solana HSV 1+2/VZV Assay
K162451 · PGI
Quidel Corporation
Microbiology · 88d
Cleared Nov 23, 2016
Xpert MRSA NxG
K162444 · NQX
Cepheid
Microbiology · 84d
Cleared Nov 15, 2016
HardyCHROM ESBL
K160512 · JSO
Hardy Diagnostics
Microbiology · 265d
Cleared Nov 04, 2016
Puritan Fecal Opti-Swab Collection and Transport System
K162284 · JSM
Puritan Medical Products, LLC
Microbiology · 81d
Cleared Oct 31, 2016
BreathID Hp Lab System
K162150 · MSQ
Exalenz Bioscience , Ltd.
Microbiology · 90d
Not Cleared Oct 28, 2016
BD MAX Vaginal Panel, BD MAX Instrument
DEN160001 · PQA
Geneohm Sciences Canada, Inc. (Bd...
Microbiology · 291d
Cleared Oct 25, 2016
Solana Strep Complete Assay
K162274 · PGX
Quidel Corporation
Microbiology · 74d
Cleared Oct 25, 2016
chromID MRSA
K162076 · JSO
bioMerieux, Inc.
Microbiology · 90d
Cleared Oct 13, 2016
ADVIA Centaur HAV IgM Assay
K161964 · LOL
Siemens Healthcare Diagnostics, Inc.
Microbiology · 87d
Not Cleared Oct 06, 2016
APAS Compact with Urine Analysis Module
DEN150059 · PPU
Clever Culture Systems AG
Microbiology · 287d
Cleared Oct 03, 2016
FilmArray Respiratory Panel EZ (RP EZ)
K152579 · OCC
Biofire Diagnostics, LLC
Microbiology · 389d
Cleared Oct 01, 2016
SeraQuest Herpes Type 1 Specific IgG
K162276 · MXJ
Quest International, Inc.
Microbiology · 50d
Cleared Sep 27, 2016
Solana Influenza A+B Assay
K161814 · OCC
Quidel Corporation
Microbiology · 88d
Cleared Sep 06, 2016
BD MAX CT/GC/TV, BD MAX INSTRUMENT
K151589 · OUY
Becton, Dickinson and Company
Microbiology · 452d
Cleared Sep 02, 2016
FilmArray RP EZ Control Panel M265
K161573 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 87d
Cleared Aug 29, 2016
Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I,...
K161619 · OUY
Cepheid
Microbiology · 77d