FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
697–720 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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 Mar 08, 2018
BreathID Hp Lab System
K173777 · MSQ
Exalenz Bioscience , Ltd.
Microbiology · 86d
Cleared 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
Cleared Dec 21, 2017
Solana GBS Assay
K173250 · NJR
Quidel Corporation
Microbiology · 72d
Cleared Dec 21, 2017
Sofia Strep A+ FIA, Sofia 2 Analyzer
K171976 · GTY
Quidel Corporation
Microbiology · 174d
Cleared Dec 19, 2017
Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL
K173307 · JWY
Liofilchem S. R. L.
Microbiology · 62d
Cleared Dec 19, 2017
VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL
K172944 · LON
bioMerieux, Inc.
Microbiology · 84d