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
529–552 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Nov 12, 2019
xTAG Gastrointestinal Pathogen Panel (GPP)
K191161 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 195d
Cleared Nov 07, 2019
B. anthracis Real-time PCR Assay
K192871 · NHT
Centers For Disease Control and...
Microbiology · 30d
Cleared Nov 06, 2019
Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin...
K192729 · JWY
Thermo Fisher Scientific
Microbiology · 40d
Cleared Nov 06, 2019
Thermo Scientific Sensititre ARIS HiQ System
K191918 · LRG
Thermo Fisher Scientific
Microbiology · 111d
Cleared Nov 06, 2019
Thermo Scientific Sensititre ARIS HiQ System
K191914 · LRG
Thermo Fisher Scientific
Microbiology · 112d
Cleared Nov 04, 2019
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS...
K191160 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 187d
Cleared Oct 31, 2019
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
K192345 · JWY
Liofilchem S. R. L.
Microbiology · 63d
Cleared Oct 31, 2019
Vitek Densichek
K192110 · LON
bioMerieux, Inc.
Microbiology · 87d
Cleared Oct 28, 2019
LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
K192046 · QFO
DiaSorin, Inc.
Microbiology · 89d
Cleared Oct 21, 2019
BD MAX Vaginal Panel
K191957 · PQA
Geneohm Sciences Canada, Inc. (Bd...
Microbiology · 90d
Cleared Oct 16, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K192250 · JWY
Thermo Fisher Scientific
Microbiology · 58d
Not Cleared Oct 10, 2019
OraQuick Ebola Rapid Antigen Test
DEN190025 · QID
OraSure Technologies, Inc.
Microbiology · 150d
Cleared Oct 07, 2019
Cepheid Xpert Respiratory Control Panel
K190086 · PMN
Microbiologics, Inc.
Microbiology · 263d
Cleared Oct 02, 2019
NG-Test CARBA 5
K191889 · PTJ
Ng Biotech
Microbiology · 79d
Cleared Oct 01, 2019
Applied Biosystems Bacillus anthracis Detection Kit
K183462 · QIF
Mriglobal
Microbiology · 291d
Cleared Sep 27, 2019
ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
K192050 · JWY
Biomerieux S.A.
Microbiology · 58d
Cleared Sep 25, 2019
ARIES MRSA Assay
K191742 · NQX
Luminex Corporation
Microbiology · 86d
Cleared Sep 19, 2019
HardyDisk AST Lefamulin 20µg (LMU20)
K192326 · JTN
Hardy Diagnostics
Microbiology · 23d
Cleared Sep 04, 2019
MTS Imipenem 0.016-256 µg/mL
K191908 · JWY
Liofilchem S. R. L.
Microbiology · 50d
Cleared Aug 29, 2019
BD MAX Check-Points CPO
K190613 · POC
Check-Points Health B.V.
Microbiology · 171d
Cleared Aug 23, 2019
MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
K191809 · JWY
Liofilchem S. R. L.
Microbiology · 49d
Cleared Aug 22, 2019
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
K191953 · JWY
Biomerieux S.A.
Microbiology · 31d
Cleared Aug 13, 2019
Elecsys Anti-HAV II
K190428 · LOL
Roche Diagnostics
Microbiology · 172d
Cleared Aug 08, 2019
binx health io CT/NG Assay
K191352 · QEP
Binx Health, Inc.
Microbiology · 80d