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
337–360 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 13, 2023
BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
K230719 · QOF
Biofire Diagnostics, LLC
Microbiology · 29d
Cleared Apr 05, 2023
BioSci™ Disposable Virus Sampling Tubes
K230035 · JSM
Shenzhen Dakewe Bio-Engineering Co.,...
Microbiology · 90d
Cleared Apr 05, 2023
MicroScan Prompt Inoculation System-D
K221493 · LIE
Beckman Coulter, Inc.
Microbiology · 317d
Cleared Apr 03, 2023
iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
K221802 · QBD
Mawi Dna Technologies
Microbiology · 286d
Cleared Mar 24, 2023
BD BACTEC™ Plus Aerobic/F Culture Vials
K222591 · MDB
Becton, Dickinson and Company
Microbiology · 210d
Cleared Mar 24, 2023
BD BACTEC™ Myco/F Lytic Culture Vials
K222559 · MDB
Becton, Dickinson and Company
Microbiology · 212d
Cleared Mar 23, 2023
MeMed BV
K222332 · QPS
MeMed Diagnostics, Ltd.
Microbiology · 233d
Cleared Mar 22, 2023
BioFire Global Fever Special Pathogens Panel
K213362 · QVR
Biofire Defense, LLC
Microbiology · 526d
Cleared Mar 21, 2023
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K223844 · JWY
Thermo Fisher Scientific
Microbiology · 89d
Cleared Mar 20, 2023
Colibrí
K223245 · QQV
Copan Wasp Srl
Microbiology · 151d
Cleared Mar 17, 2023
Simplexa COVID-19 & Flu A/B Direct
K220963 · QOF
Diasorin Molecular, LLC
Microbiology · 350d
Cleared Mar 16, 2023
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
K230404 · PCH
Biofire Diagnostics, LLC
Microbiology · 29d
Cleared Mar 10, 2023
Lyra RSV+hMPV Assay
K230349 · OEM
Quidel Corporation
Microbiology · 29d
Cleared Mar 10, 2023
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution...
K221198 · NGZ
Thermo Fisher Scientific
Microbiology · 318d
Cleared Mar 09, 2023
VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN...
K222430 · LON
Biomerieux Sa, Inc.
Microbiology · 210d
Not Cleared Mar 08, 2023
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
DEN220039 · QVF
Quidel Corporation
Microbiology · 265d
Cleared Mar 07, 2023
Visby Medical Sexual Health Test
K220407 · QEP
Visby Medical
Microbiology · 386d
Cleared Mar 06, 2023
BD Vaginal Panel
K223653 · PQA
Becton, Dickinson and Company
Microbiology · 90d
Cleared Mar 03, 2023
Lyra Influenza A+B Assay
K230236 · OZE
Quidel Corporation
Microbiology · 32d
Cleared Mar 03, 2023
Alinity m STI Assay
K222379 · QEP
Abbott Molecular, Inc.
Microbiology · 210d
Cleared Feb 17, 2023
Spectrum Saliva Collection Device
K223497 · QBD
Spectrum Solutions, LLC
Microbiology · 88d
Cleared Feb 16, 2023
VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL)
K223478 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Feb 09, 2023
VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
K222073 · LON
bioMerieux, Inc.
Microbiology · 210d
Cleared Feb 03, 2023
VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)
K223481 · LON
bioMerieux, Inc.
Microbiology · 77d