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
649–672 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jan 08, 2019
BD MAX CTGCTV2, BD MAX System
K182692 · OUY
Becton, Dickinson and Company
Microbiology · 103d
Cleared Jan 04, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K183033 · JWY
Thermo Fisher Scientific
Microbiology · 64d
Cleared Dec 21, 2018
ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
K182690 · PEO
Genmark Diagnostics, Incorporated
Microbiology · 85d
Cleared Dec 21, 2018
VITEK MS
K181412 · QBN
bioMerieux, Inc.
Microbiology · 205d
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