Cleared Traditional

CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)

K961148 · Difco Laboratories, Inc. · Microbiology
Apr 1996
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K961148 is an FDA 510(k) clearance for the CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG), a System, Transport, Aerobic (Class I — General Controls, product code JTW), submitted by Difco Laboratories, Inc. (Livouia, US). The FDA issued a Cleared decision on April 26, 1996, 36 days after receiving the submission on March 21, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K961148 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1996
Decision Date April 26, 1996
Days to Decision 36 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JTW — System, Transport, Aerobic
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2900

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