Cleared Traditional

HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40

K152846 · Hardy Diagnostics · Microbiology
Nov 2015
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K152846 is an FDA 510(k) clearance for the HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40, 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 November 24, 2015, 56 days after receiving the submission on September 29, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K152846 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2015
Decision Date November 24, 2015
Days to Decision 56 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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