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
25–48 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 14, 2026
BD BBL Mueller Hinton II Broth (Cation-Adjusted)
K262163 · JTZ
Becton, Dickinson and Company
Microbiology · 80d
Cleared Sep 11, 2026
FINDER Flu A&B/SARS-CoV-2 Test
K261837 · QOF
Baebies, Inc.
Microbiology · 101d
Cleared Sep 04, 2026
Sofia 2 SARS Antigen+ FIA
K254264 · QVF
Ortho-Clinical Diagnostics, Inc....
Microbiology · 248d
Cleared Sep 04, 2026
Sofia Influenza A+B FIA
K254262 · PSZ
Ortho-Clinical Diagnostics, Inc....
Microbiology · 248d
Cleared Aug 28, 2026
cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190)
K260047 · PGX
Roche Molecular Systems, Inc.
Microbiology · 233d
Cleared Aug 28, 2026
cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190)
K260045 · OZN
Roche Molecular Systems, Inc.
Microbiology · 233d
Cleared Aug 20, 2026
HardyDisk AST Tebipenem 10µg (TBP10)
K262113 · JTN
Hardy Diagnostics
Microbiology · 58d
Cleared CT Aug 07, 2026
Xpert Hemorrhagic Fever
K261362 · QVR
Cepheid
Microbiology · 102d
Cleared Aug 07, 2026
Metrix COVID Test
K253453 · QWB
Aptitude Medical Systems, Inc.
Microbiology · 305d
Cleared Aug 06, 2026
QIAstat-Dx BCID GPF Plus AMR Panel
K254194 · PAM
QIAGEN GmbH
Microbiology · 226d
Cleared Jul 24, 2026
Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60
K261781 · JTN
Thermo Fisher Scientific (Oxoid Ltd.)
Microbiology · 56d
Cleared Jul 23, 2026
Gepotidacin GEP 10 µg
K261853 · JTN
Liofilchem, Inc.
Microbiology · 50d
Cleared Jul 17, 2026
BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
K261475 · PMN
Biofire Defense, LLC
Microbiology · 73d
Cleared Jul 16, 2026
cobas® BV/CV
K260021 · PQA
Roche Molecular Systems, Inc.
Microbiology · 192d
Cleared Jul 10, 2026
Flowflex Plus RSV + Flu A/B + COVID Rapid Test
K261212 · SCA
ACON Laboratories, Inc.
Microbiology · 87d
Cleared Jul 10, 2026
Sofia Lyme FIA
K254295 · LSR
Ortho-Clinical Diagnostics, Inc....
Microbiology · 191d
Cleared Jul 08, 2026
cobas CT/NG for use on the cobas 5800/6800/8800 systems
K260917 · QEP
Roche Molecular Systems, Inc.
Microbiology · 111d
Cleared Jul 08, 2026
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
K260160 · SAN
bioMerieux, Inc.
Microbiology · 169d
Cleared Jul 02, 2026
Xpert Carba-R
K261867 · POC
Cepheid
Microbiology · 28d
Cleared Jun 26, 2026
PhAST instrument and PhAST Blood Culture Gram-negative Panel
K253316 · SAN
Phast Corp.
Microbiology · 269d
Cleared Jun 15, 2026
LIAISON NES Group A Strep
K260333 · PGX
Diasorin Molecular, LLC
Microbiology · 133d
Cleared Jun 12, 2026
Fast PCR Mini Respiratory Panel
K252932 · QOF
Autonomous Medical Devices Incorporated
Microbiology · 270d
Cleared Jun 10, 2026
Colli-Pee•Dx Urine Collection Kit
K254121 · SIH
DNA Genotek, Inc.
Microbiology · 173d
Cleared Jun 05, 2026
Fastep COVID-19 Antigen Pen Home Test
K260754 · QYT
Assure Tech., LLC
Microbiology · 88d