Cleared Traditional

HardyDisk AST Cefiderocol 30?g (FDC30)

K241060 · Hardy Diagnostics · Microbiology
Jul 2024
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K241060 is an FDA 510(k) clearance for the HardyDisk AST Cefiderocol 30?g (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 July 18, 2024, 91 days after receiving the submission on April 18, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K241060 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2024
Decision Date July 18, 2024
Days to Decision 91 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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