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
337–360 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 31, 2023
BD Respiratory Viral Panel for BD MAX™ System
K230956 · QOF
Bd Integrated Diagnostic Solutions /
Microbiology · 118d
Cleared Jul 27, 2023
MDx-Chex for BC-GN
K231223 · PMN
Streck
Microbiology · 90d
Cleared Jul 27, 2023
MDx-Chex for BC-GP
K231221 · PMN
Streck
Microbiology · 90d
Cleared Jul 27, 2023
cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas®...
K223591 · QOF
Roche Molecular Systems, Inc.
Microbiology · 238d
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 CT 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 CT 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