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
337–360 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Feb 03, 2023
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
K221253 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 277d
Cleared Feb 03, 2023
BIOFIRE SPOTFIRE Respiratory (R) Panel
K213954 · QOF
Biofire Diagnostics
Microbiology · 413d
Not Cleared Feb 03, 2023
Active Anthrax DetectTM Plus Rapid Test
DEN220044 · QUU
InBios International, Inc.
Microbiology · 210d
Cleared Jan 27, 2023
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
K223016 · PSZ
Bd
Microbiology · 120d
Cleared Jan 27, 2023
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP...
K220803 · LON
bioMerieux, Inc.
Microbiology · 315d
Cleared Jan 26, 2023
Revogene
K222779 · OOI
Meridian Bioscience, Inc.
Microbiology · 134d