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
313–336 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 13, 2023
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System
K230863 · LSR
Zeus Scientific
Microbiology · 106d
Cleared Jul 06, 2023
HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
K231568 · JTN
Hardy Diagnostics
Microbiology · 36d
Cleared Jul 05, 2023
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP...
K230864 · LON
bioMerieux, Inc.
Microbiology · 98d
Cleared Jul 03, 2023
Premier HpSA Flex (619096)
K230901 · LYR
Meridian Bioscience, Inc.
Microbiology · 94d
Cleared Jul 03, 2023
CLEARinse CTS Specimen Collection and Transport System
K221664 · QBD
Aardvark Medical, Inc.
Microbiology · 390d
Cleared Jun 30, 2023
MeMed BV
K230944 · QPS
MeMed Diagnostics, Ltd.
Microbiology · 87d
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