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
313–336 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 30, 2023
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or...
K230935 · JWY
Thermo Fisher Scientific
Microbiology · 88d
Cleared Jun 30, 2023
FebriDx Bacterial / Non-bacterial Point of Care Assay
K230917 · QXA
Lumos Diagnostics, Inc.
Microbiology · 88d
Cleared Jun 26, 2023
VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL)
K222378 · LON
bioMerieux, Inc.
Microbiology · 325d
Cleared Jun 07, 2023
BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)
K230651 · JTN
Becton, Dickinson and Company
Microbiology · 90d
Not Cleared Jun 06, 2023
Cue COVID-19 Molecular Test
DEN220028 · QWB
Cue Health, Inc.
Microbiology · 400d
Cleared Jun 01, 2023
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
K231306 · QQX
Roche Molecular Systems, Inc.
Microbiology · 27d
Cleared Jun 01, 2023
HardyDisk AST Rezafungin 5µg (RZF5)
K230827 · JTN
Hardy Diagnostics
Microbiology · 66d
Cleared May 18, 2023
ComASP Cefiderocol 0.008-128
K230479 · JWY
Liofilchem S. R. L.
Microbiology · 85d
Cleared May 16, 2023
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
K222736 · QOF
Hologic, Inc.
Microbiology · 249d
Cleared May 05, 2023
Panther Fusion AdV/hMPV/RV Assay
K231017 · OCC
Hologic, Inc.
Microbiology · 25d
Not Cleared May 05, 2023
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS...
DEN210040 · QVP
Ortho-Clinical Diagnostics, Inc.
Microbiology · 591d
Not Cleared May 05, 2023
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS...
DEN210038 · QVP
Ortho-Clinical Diagnostics, Inc.
Microbiology · 592d
Cleared May 04, 2023
BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application,...
K213280 · QQY
Bd Kiestra B.V.
Microbiology · 580d
Cleared May 03, 2023
MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
K212743 · JSM
Medschenker, Inc.
Microbiology · 611d
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