Cleared Traditional

HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939

K103538 · Hardy Diagnostics · Microbiology
Dec 2010
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K103538 is an FDA 510(k) clearance for the HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on December 17, 2010, 15 days after receiving the submission on December 2, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K103538 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2010
Decision Date December 17, 2010
Days to Decision 15 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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