Cleared Traditional

TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K060286 · Oxoid , Ltd. · Microbiology
Mar 2006
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K060286 is an FDA 510(k) clearance for the TIGECYCLINE 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 17, 2006, 42 days after receiving the submission on February 3, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K060286 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2006
Decision Date March 17, 2006
Days to Decision 42 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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