Cleared Traditional

HardyDisk AST Gepotidacin 10?g (GEP10)

K250956 · Hardy Diagnostics · Microbiology
Jun 2025
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K250956 is an FDA 510(k) clearance for the HardyDisk AST Gepotidacin 10?g (GEP10), a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Hardy Diagnostics (Santa Monica, US). The FDA issued a Cleared decision on June 26, 2025, 87 days after receiving the submission on March 31, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K250956 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2025
Decision Date June 26, 2025
Days to Decision 87 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JTN — Susceptibility Test Discs, Antimicrobial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1620

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