Cleared Traditional

HardyDisk AST Imipenem/relebactam 10/25?g (IMR10/25)

K191931 · Hardy Diagnostics · Microbiology
Jul 2019
Decision
12d
Days
Class 2
Risk

About This 510(k) Submission

K191931 is an FDA 510(k) clearance for the HardyDisk AST Imipenem/relebactam 10/25?g (IMR10/25), 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 July 31, 2019, 12 days after receiving the submission on July 19, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K191931 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2019
Decision Date July 31, 2019
Days to Decision 12 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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