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
553–576 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jan 08, 2020
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K193024 · JWY
Thermo Fisher Scientific
Microbiology · 70d
Cleared Dec 23, 2019
BioCode Respiratory Pathogen Panel (RPP)
K192485 · OCC
Applied BioCode, Inc.
Microbiology · 104d
Cleared Dec 20, 2019
Unyvero LRT BAL Application
K191967 · QBH
Curetis GmbH
Microbiology · 150d
Cleared Dec 11, 2019
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files,...
K193167 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 26d
Not Cleared Dec 05, 2019
cobas vivoDx MRSA
DEN190016 · QIV
Roche Molecular Systems, Inc.
Microbiology · 261d
Not Cleared Dec 02, 2019
WOUNDCHEK Bacterial Status
DEN180014 · QFA
Alere Scarborough, Inc.
Microbiology · 619d
Cleared Nov 26, 2019
ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
K192738 · JWY
Biomerieux S.A.
Microbiology · 60d
Cleared Nov 26, 2019
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
K192376 · PGI
Diasorin Molecular, LLC
Microbiology · 88d
Cleared Nov 26, 2019
Access PCT, Access PCT Calibrators
K192271 · PTF
Beckman Coulter, Inc.
Microbiology · 96d
Cleared Nov 14, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer)...
K192355 · JWY
Beckman Coulter, Inc.
Microbiology · 77d
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