Cleared Traditional

ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K070262 · Oxoid , Ltd. · Microbiology
Mar 2007
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K070262 is an FDA 510(k) clearance for the ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Oxoid , Ltd. (Basingstoke, GB). The FDA issued a Cleared decision on March 14, 2007, 47 days after receiving the submission on January 26, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K070262 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2007
Decision Date March 14, 2007
Days to Decision 47 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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