Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Microbiology ×
7,095 results
457–480 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 02, 2022
NATtrol BD MAX Vaginal Panel External Controls
K201403 · PMN
Zeptometrix
Microbiology · 615d
Cleared Jan 19, 2022
MDx-Chex for BCID2
K212576 · PMN
Streck, Inc.
Microbiology · 156d
Cleared Dec 27, 2021
Colibri System
K193138 · QQV
Copan Wasp Srl
Microbiology · 775d
Cleared Dec 23, 2021
Curian Campy
K210976 · LQP
Meridian Bioscience, Inc.
Microbiology · 266d
Cleared Dec 20, 2021
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K203741 · JWY
Thermo Fisher Scientific
Microbiology · 363d
Cleared Dec 17, 2021
Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and...
K193081 · QEP
Rheonix, Inc.
Microbiology · 773d
Cleared Dec 15, 2021
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution...
K211539 · NGZ
Thermo Fisher Scientific
Microbiology · 211d
Cleared Nov 29, 2021
SeptiCyte RAPID
K203748 · PRE
Immunexpress, Inc.
Microbiology · 341d
Cleared Nov 23, 2021
Sofia 2 Campylobacter FIA
K211342 · LQP
Quidel Corporation
Microbiology · 204d
Cleared Nov 12, 2021
ETEST Fosfomycin (FO) (0.032-512 µg/mL)
K210757 · JWY
Biomerieux S.A.
Microbiology · 242d
Cleared Nov 03, 2021
BD Kiestra IdentifA
K191964 · QQV
Becton, Dickinson and Company
Microbiology · 834d
Not Cleared Nov 03, 2021
OMNIgene GUT Dx
DEN200040 · QPO
DNA Genotek, Inc.
Microbiology · 506d
Cleared Nov 01, 2021
BioFire COVID-19 Test 2
K211079 · QQX
Biofire Defense, LLC
Microbiology · 203d
Cleared Oct 28, 2021
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
K210287 · LON
bioMerieux, Inc.
Microbiology · 268d
Cleared Oct 28, 2021
APAS Independence with IC Chromogenic MRSA BD Analysis Module
K200839 · QQY
Clever Culture Systems
Microbiology · 576d
Cleared Oct 27, 2021
Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
K210873 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 217d
Cleared Oct 20, 2021
cobas Cdiff nucleic acid test for use on the cobas Liat System
K212427 · OZN
Roche Molecular Systems, Inc.
Microbiology · 77d
Cleared Oct 20, 2021
MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
K211672 · JWY
Liofilchem S. R. L.
Microbiology · 141d
Cleared Oct 20, 2021
InTray GC
K210511 · JTY
Biomed Diagnostics Incorporated
Microbiology · 239d
Cleared Oct 18, 2021
BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit
K201017 · PQA
Geneohm Sciences Canada, Inc. (Bd...
Microbiology · 549d
Cleared Sep 30, 2021
Acuitas AMR Gene Panel
K191288 · PMY
Opgen, Inc.
Microbiology · 871d
Cleared Sep 22, 2021
FilmArray Pneumonia Panel
K212727 · QDP
Biofire Diagnostics, LLC
Microbiology · 26d
Cleared Sep 20, 2021
Disposable Sampler Inactivated Transport Media, Nest ITM
K210440 · QBD
Wuxi Nest Biotechnology Co., Ltd.
Microbiology · 220d
Cleared Sep 14, 2021
VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
K202396 · LON
bioMerieux, Inc.
Microbiology · 389d