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
1–24 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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 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
Cleared Jun 04, 2026
LIAISON Murex HBsAg Qual
K260770 · LOM
DiaSorin, Inc.
Microbiology · 87d
Cleared Jun 01, 2026
CorDx Tyfast COVID-19 Ag Rapid Test Rx
K253882 · QVF
CorDx, Inc.
Microbiology · 179d
Cleared May 28, 2026
BD BACTEC FXI Culture System
K260213 · MDB
Bd Diagnostic Systems
Microbiology · 125d
Cleared May 27, 2026
Visby Medical Flu and COVID-19 Test
K253971 · SIA
Visby Medical, Inc.
Microbiology · 167d