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
193–216 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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 Sep 25, 2024
IVD CAPSULE PSP
K240041 · SCX
Abionic SA
Microbiology · 264d
Cleared Sep 13, 2024
T2Candida 1.1 Panel
K234063 · PII
T2biosystems, Inc.
Microbiology · 266d
Cleared Sep 06, 2024
Access Syphilis
K241427 · LIP
Beckman Coulter, Inc.
Microbiology · 109d
Cleared Aug 30, 2024
Alinity i Toxo IgM
K233932 · LGD
Abbott Laboratories
Microbiology · 260d
Cleared Aug 29, 2024
Ensol EnTM Specimen Collection and Transport System
K220908 · JSM
Ensol Biosciences, Inc.
Microbiology · 884d
Cleared Aug 28, 2024
VITROS Immunodiagnostic Products Syphilis Reagent Pack
K241534 · LIP
Ortho-Clinical Diagnostics
Microbiology · 90d
Cleared Aug 23, 2024
SCoV-2 Ag Detect Rapid Test
K233358 · QVF
InBios International, Inc.
Microbiology · 329d
Cleared Aug 19, 2024
OmniTrans Transport System
K240235 · JSM
Shenzhen Dakewe Bio-Engineering Co.,...
Microbiology · 203d
Not Cleared Aug 16, 2024
First To Know Syphilis Test
DEN230090 · SBZ
Nowdiagnostics
Microbiology · 233d
Cleared Aug 12, 2024
iDart Lyme IgG ImmunoBlot Kit
K233367 · LSR
Id-Fish Technology, Inc.
Microbiology · 315d
Cleared Aug 07, 2024
ADVIA Centaur EBV-VCA IgM
K233606 · LSE
Biokit, S.A.
Microbiology · 272d