Cleared Traditional

HardyDisk AST Plazomicin 30ug (PLZ30)

K181700 · Hardy Diagnostics · Microbiology
Jul 2018
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K181700 is an FDA 510(k) clearance for the HardyDisk AST Plazomicin 30ug (PLZ30), 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 10, 2018, 13 days after receiving the submission on June 27, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K181700 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2018
Decision Date July 10, 2018
Days to Decision 13 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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