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
145–168 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Jun 17, 2025
Nano-Check Influenza+COVID-19 Dual Test
K243561 · SCA
Nano-Ditech Corporation
Microbiology · 211d
Cleared Jun 16, 2025
BD Veritor System for SARS-CoV-2
K243872 · QVF
Becton, Dickinson and Company
Microbiology · 181d
Cleared Jun 13, 2025
BinaxNOW COVID-19 Ag Card
K250273 · QVF
Abbott Diagnostics Scarborough, Inc.
Microbiology · 134d
Cleared Jun 12, 2025
ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)
K250856 · JWY
Biom?rieux
Microbiology · 83d
Cleared Jun 12, 2025
Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
K250789 · JTN
Thermo Fisher Scientific (Oxoid Ltd.)
Microbiology · 90d
Cleared Jun 12, 2025
iDart Lyme IgM ImmunoBlot Kit
K242872 · LSR
Id-Fish Technology, Inc.
Microbiology · 262d
Cleared Jun 10, 2025
Elecsys Anti-SARS-CoV-2
K250768 · QVP
Roche Diagnostics
Microbiology · 89d
Cleared Jun 06, 2025
LIAISON PLEX Gram-Positive Blood Culture Assay
K243490 · PAM
Luminex Corporation
Microbiology · 206d
Cleared Jun 04, 2025
NG-Test® CTX-M MULTI
K243499 · PTJ
Ng Biotech
Microbiology · 204d
Cleared May 30, 2025
OHC COVID-19 Antigen Self Test
K241313 · QYT
Osang, LLC
Microbiology · 386d
Cleared May 27, 2025
Puritan PurSafe Plus Collection and Transport System
K242820 · QBD
Puritan Medical Products, LLC
Microbiology · 251d
Cleared May 22, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242659 · JWY
Thermo Fisher Scientific
Microbiology · 260d
Cleared May 19, 2025
BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4...
K250447 · LON
Becton, Dickinson and Company
Microbiology · 90d
Cleared May 15, 2025
HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
K250454 · JTN
Hardy Diagnostics
Microbiology · 86d
Cleared May 10, 2025
Flowflex Plus COVID-19 + Flu A/B Home Test
K250377 · SCA
ACON Laboratories, Inc.
Microbiology · 89d
Cleared May 09, 2025
DiaSys Procalcitonin FS
K242294 · PTF
Diasys Diagnostic Systems GmbH
Microbiology · 280d
Not Cleared May 09, 2025
Teal Wand
DEN240045 · SEP
Teal Health, Inc.
Microbiology · 255d
Cleared May 01, 2025
Xpert Xpress CoV-2/Flu/RSV plus
K250996 · QOF
Cepheid
Microbiology · 30d
Cleared May 01, 2025
Xpert Xpress CoV-2/Flu/RSV plus
K250995 · QOF
Cepheid
Microbiology · 30d
Cleared Apr 30, 2025
ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
K250274 · JWY
Biomerieux S.A.
Microbiology · 90d