Cleared Traditional

HardyDisk AST Delafloxacin 5 ?g (DLX5)

K171975 · Hardy Diagnostics · Microbiology
Aug 2017
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K171975 is an FDA 510(k) clearance for the HardyDisk AST Delafloxacin 5 ?g (DLX5), 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 August 1, 2017, 32 days after receiving the submission on June 30, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K171975 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2017
Decision Date August 01, 2017
Days to Decision 32 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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