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
361–384 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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 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
Cleared Oct 27, 2022
Architect CMV IgG
K220949 · LFZ
Abbott Laboratories
Microbiology · 209d
Cleared Oct 22, 2022
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
K213804 · QQX
Roche Molecular Systems, Inc.
Microbiology · 320d
Cleared Oct 20, 2022
BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global...
K220870 · QMV
Biofire Defense, LLC
Microbiology · 209d
Cleared Oct 13, 2022
VITEK 2 AST-Gram Positive Cefoxitin Screen
K220805 · LON
bioMerieux, Inc.
Microbiology · 209d