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
361–384 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 26, 2023
Access PCT
K222996 · PTF
Beckman Coulter, Inc.
Microbiology · 210d
Cleared Apr 19, 2023
Selux AST System
K211748 · LON
Selux Diagnostics, Inc.
Microbiology · 681d
Cleared Apr 17, 2023
Curian® Shiga Toxin
K222829 · GMZ
Meridian Bioscience, Inc.
Microbiology · 210d
Cleared Apr 13, 2023
SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE®...
K230868 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 15d
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