Cleared Traditional

MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K010536 · Oxoid , Ltd. · Microbiology
Apr 2001
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K010536 is an FDA 510(k) clearance for the MOXIFLOXACIN 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 April 24, 2001, 60 days after receiving the submission on February 23, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K010536 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2001
Decision Date April 24, 2001
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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