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
385–408 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Jan 20, 2023
The Sensititre YeastOne Susceptibility System with Caspofungin in the...
K221899 · NGZ
Thermo Fisher Scientific
Microbiology · 204d
Cleared Jan 19, 2023
Biosci™ Inactivated Transport Medium, Biosci™ ITM
K220059 · QBD
Shenzhen Dakewe Bio-Engineering Co.,...
Microbiology · 374d
Cleared Jan 18, 2023
Selux AST System
K211759 · LON
Selux Diagnostics, Inc.
Microbiology · 590d
Cleared Jan 04, 2023
Elecsys Anti-HCV II (08837031190)
K221693 · MZO
Roche Diagnostics
Microbiology · 208d
Cleared Dec 21, 2022
BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
K221826 · JTN
Becton, Dickinson and Company
Microbiology · 181d
Cleared CT Dec 20, 2022
IntelliSep test
K220991 · QUT
Cytovale, Inc.
Microbiology · 260d
Cleared Dec 19, 2022
BreathID Hp System
K221896 · MSQ
Meridian Bioscience Israel , Ltd.
Microbiology · 172d
Cleared Dec 16, 2022
Copan FecalSwab Collection, Transport and Preservation System
K220052 · JSM
Copan Italia Spa
Microbiology · 344d
Cleared Dec 09, 2022
LIAISON Anti-HAV
K223403 · LOL
DiaSorin, Inc.
Microbiology · 30d
Cleared Nov 17, 2022
Disposable Urine Collection Tube
K220739 · JSM
Zhejiang Gongdong Medical Technology...
Microbiology · 248d
Cleared Nov 10, 2022
BreathID® Smart System
K223185 · MSQ
Meridian Bioscience Israel , Ltd.
Microbiology · 29d
Cleared Nov 05, 2022
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
K202755 · QDZ
Diasorin Molecular, LLC
Microbiology · 775d
Cleared Nov 04, 2022
cobas HCV
K221007 · MZP
Roche Molecular Systems, Inc.
Microbiology · 213d
Cleared Oct 27, 2022
FilmArray Pneumonia Panel plus
K222601 · QDS
Biofire Diagnostics, LLC
Microbiology · 59d