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
97–120 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 27, 2025
QIAstat-Dx Respiratory Panel Plus
K250080 · QOF
QIAGEN GmbH
Microbiology · 226d
Cleared Aug 22, 2025
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
K251604 · SCA
Access Bio, Inc.
Microbiology · 87d
Cleared Aug 21, 2025
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
K251579 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Aug 20, 2025
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
K251580 · JWY
Liofilchem S. R. L.
Microbiology · 89d
Cleared Aug 20, 2025
WELLlife Flu A&B Home Test
K251563 · SCA
Wondfo USA Co., Ltd.
Microbiology · 90d
Cleared Aug 20, 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64...
K243804 · LTT
Beckman Coulter, Inc.
Microbiology · 252d
Cleared Aug 15, 2025
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32...
K250036 · LTT
Beckman Coulter, Inc.
Microbiology · 219d
Cleared Aug 14, 2025
FilmArray GI Control Panel M238
K251526 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 87d
Cleared Aug 14, 2025
BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
K243544 · QOF
Biofire Diagnostics, LLC
Microbiology · 272d
Cleared Aug 13, 2025
MBT Compass HT CA Software
K251495 · QBN
Bruker Daltonics GmbH & Co. KG
Microbiology · 90d
Cleared Aug 12, 2025
Sulopenem SPM 2 µg
K251879 · JTN
Liofilchem
Microbiology · 55d
Cleared Aug 08, 2025
BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
K251713 · LON
Becton, Dickinson and Company
Microbiology · 66d
Cleared Aug 01, 2025
MycoMEIA Aspergillus Assay
K243496 · NOM
Pearl Diagnostics, Inc.
Microbiology · 262d
Cleared Jul 31, 2025
cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
K243455 · QOF
Roche Molecular Systems, Inc.
Microbiology · 266d
Cleared Jul 28, 2025
Alinity m EBV (09N43-095)
K243489 · QLX
Abbott Molecular, Inc.
Microbiology · 258d
Cleared Jul 18, 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64...
K250084 · LTT
Beckman Coulter, Inc.
Microbiology · 186d
Cleared Jul 11, 2025
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B...
K243274 · OZE
Centers For Disease Control and...
Microbiology · 268d
Cleared Jul 03, 2025
Innovita Flu A/B Antigen Rapid Test
K250398 · PSZ
Innovita (Tangshan) Biological...
Microbiology · 141d
Cleared Jul 01, 2025
Alinity m CMV
K243485 · PAB
Abbott Molecular, Inc.
Microbiology · 235d
Cleared Jun 30, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K250990 · JWY
Thermo Fisher Scientific
Microbiology · 91d
Cleared Jun 26, 2025
HardyDisk AST Gepotidacin 10µg (GEP10)
K250956 · JTN
Hardy Diagnostics
Microbiology · 87d
Cleared Jun 23, 2025
Ceftobiprole BPR 5 µg Disc
K250885 · JTN
Liofilchem, Inc.
Microbiology · 90d
Cleared Jun 20, 2025
Alinity i Rubella IgG
K243168 · LFX
Abbott Laboratories
Microbiology · 263d
Cleared Jun 20, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242843 · JWY
Thermo Fisher Scientific
Microbiology · 273d