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
217–240 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 18, 2024
Xpert MRSA/SA SSTI
K243625 · NQX
Cepheid
Microbiology · 23d
Cleared Dec 06, 2024
Alinity m SARS-CoV-2 AMP Kit (09N78-096)
K241580 · QQX
Abbott Molecular
Microbiology · 186d
Cleared Dec 05, 2024
BIOFIRE FILMARRAY Tropical Fever Panel
K243463 · QMV
Biofire Diagnostics, LLC (Biomerieux)
Microbiology · 27d
Cleared Dec 05, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242653 · JWY
Thermo Fisher Scientific
Microbiology · 92d
Cleared Nov 26, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242657 · JWY
Thermo Fisher Scientific
Microbiology · 83d
Cleared Nov 25, 2024
Aptima BV Assay
K243345 · PQA
Hologic, Inc.
Microbiology · 28d
Cleared Nov 21, 2024
Xpert vanA
K243405 · NIJ
Cepheid
Microbiology · 20d
Cleared Nov 15, 2024
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
K242465 · QOF
Hologic, Inc.
Microbiology · 87d
Cleared Nov 07, 2024
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
K242367 · PCH
Biofire Diagnostics, LLC
Microbiology · 90d
Cleared Nov 06, 2024
BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel)
K243222 · QDS
Biofire Diagnostics, LLC (Biomerieux)
Microbiology · 30d
Cleared Oct 29, 2024
QIAstat-Dx Meningitis/Encephalitis (ME) Panel
K242256 · PLO
QIAGEN GmbH
Microbiology · 90d
Cleared Oct 25, 2024
Xpert® SA Nasal Complete
K243070 · NQX
Cepheid
Microbiology · 28d
Cleared Oct 25, 2024
QIAstat-Dx Respiratory Panel Mini
K242353 · QOF
QIAGEN GmbH
Microbiology · 78d
Cleared Oct 23, 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
K241324 · SAN
Affinity Biosensors, LLC
Microbiology · 166d
Cleared Oct 11, 2024
Access Toxo IgM II
K242095 · LGD
Beckman Coulter, Inc.
Microbiology · 86d
Cleared Oct 11, 2024
PPH Saliva Collection Kit
K240797 · QBD
Permantis Public Health
Microbiology · 203d
Cleared Oct 11, 2024
UriSponge™
K232565 · JSM
Copan Italia Spa
Microbiology · 414d
Cleared Oct 09, 2024
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242021 · JWY
Thermo Fisher Scientific
Microbiology · 90d
Not Cleared Oct 07, 2024
Healgen Rapid Check COVID-19/Flu A&B Antigen Test
DEN240029 · SCA
Healgen
Microbiology · 122d
Cleared Oct 02, 2024
NxTAG® Respiratory Pathogen Panel
K242613 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 29d
Cleared Oct 01, 2024
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K241967 · JWY
Thermo Fisher Scientific
Microbiology · 90d
Cleared Sep 30, 2024
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
K241317 · QYT
Guangzhou Wondfo Biotech Co., Ltd.
Microbiology · 143d
Cleared Sep 26, 2024
Accelerate Arc System
K240854 · QNJ
Accelerate Diagnostics, Inc.
Microbiology · 182d
Cleared CT Sep 25, 2024
IVD CAPSULE PSP
K240041 · SCX
Abionic SA
Microbiology · 264d