Cleared Traditional

HardyDisk AST Cefiderocol 30ug (FDC30)

K193504 · Hardy Diagnostics · Microbiology
Jan 2020
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K193504 is an FDA 510(k) clearance for the HardyDisk AST Cefiderocol 30ug (FDC30), 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 January 23, 2020, 36 days after receiving the submission on December 18, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K193504 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2019
Decision Date January 23, 2020
Days to Decision 36 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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