Cleared Traditional

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

K170127 · Hardy Diagnostics · Microbiology
Mar 2017
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K170127 is an FDA 510(k) clearance for the HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-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 March 14, 2017, 60 days after receiving the submission on January 13, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K170127 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2017
Decision Date March 14, 2017
Days to Decision 60 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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