Cleared Traditional

GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K000930 · Oxoid , Ltd. · Microbiology
May 2000
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K000930 is an FDA 510(k) clearance for the GATIFLOXACIN 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 May 22, 2000, 61 days after receiving the submission on March 22, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K000930 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2000
Decision Date May 22, 2000
Days to Decision 61 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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