Cleared Traditional

DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K042157 · Oxoid , Ltd. · Microbiology
Sep 2004
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K042157 is an FDA 510(k) clearance for the DAPTOMYCIN 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 September 14, 2004, 35 days after receiving the submission on August 10, 2004. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K042157 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 2004
Decision Date September 14, 2004
Days to Decision 35 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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