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
721–744 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 23, 2018
UriSwab-Urine Collection, Transport and Preservation System
K180052 · JSM
Copan Italia Spa
Microbiology · 74d
Cleared Mar 22, 2018
Granada Medium
K173903 · PQZ
Hardy Diagnostics
Microbiology · 90d
Cleared Mar 21, 2018
cobas CT/NG for use on cobas 6800/8800 systems
K173887 · LSL
Roche Molecular Systems, Inc.
Microbiology · 90d
Cleared Mar 20, 2018
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
K180438 · PSZ
Bd
Microbiology · 28d
Not Cleared Mar 19, 2018
PrimeStore MTM
DEN170029 · QBD
Longhorn Vaccines and Diagnostics, LLC
Microbiology · 299d
Cleared Mar 16, 2018
BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins...
K173873 · MDB
Becton, Dickinson and Company
Microbiology · 86d
Cleared Mar 16, 2018
Xpert CT/NG
K173840 · LSL
Cepheid
Microbiology · 88d
Cleared Mar 15, 2018
Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL
K180330 · JWY
Liofilchem S. R. L.
Microbiology · 37d
Cleared Mar 14, 2018
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
K173798 · PGI
Diasorin Molecular, LLC
Microbiology · 90d
Cleared CT Mar 08, 2018
BreathID Hp Lab System
K173777 · MSQ
Exalenz Bioscience , Ltd.
Microbiology · 86d
Cleared CT Mar 08, 2018
BreathID Hp System
K173772 · MSQ
Exalenz Bioscience , Ltd.
Microbiology · 86d
Cleared Feb 28, 2018
Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL
K173817 · JWY
Liofilchem S. R. L.
Microbiology · 75d
Cleared Feb 28, 2018
Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
K173691 · LSR
Quidel Corporation
Microbiology · 89d
Cleared Feb 27, 2018
LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS...
K173683 · PRI
DiaSorin, Inc.
Microbiology · 88d
Cleared Feb 13, 2018
QuickVue Influenza A+B
K180288 · PSZ
Quidel Corporation
Microbiology · 12d
Cleared Feb 09, 2018
BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam...
K173523 · LON
Becton, Dickinson and Company
Microbiology · 87d
Cleared Feb 06, 2018
Accula Flu A/Flu B Test
K171641 · OZE
Mesa Biotech, Inc.
Microbiology · 249d
Cleared Feb 01, 2018
Sentosa SA201 HSV 1/2 Qualitative PCR Test
K172509 · OQO
Vela Diagnostics USA, Inc.
Microbiology · 164d
Cleared Jan 26, 2018
Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
K173932 · OCC
Alere Scarborough, Inc.
Microbiology · 31d
Cleared Jan 22, 2018
CAMPYLOBACTER CHEK
K173219 · LQP
Techlab, Inc.
Microbiology · 111d
Cleared Jan 22, 2018
CAMPYLOBACTER QUIK CHEK
K173217 · LQP
Techlab, Inc.
Microbiology · 111d
Cleared Jan 09, 2018
Xpert Carba-R
K173263 · POC
Cepheid
Microbiology · 90d
Cleared Jan 05, 2018
BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam...
K173252 · LON
Becton, Dickinson and Company
Microbiology · 87d
Cleared Dec 28, 2017
MRSASelect II
K171061 · JSO
Bio-Rad
Microbiology · 262d