Cleared Traditional

REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK

K955669 · Remel Co. · Microbiology
Feb 1996
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K955669 is an FDA 510(k) clearance for the REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on February 23, 1996, 72 days after receiving the submission on December 13, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K955669 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 1995
Decision Date February 23, 1996
Days to Decision 72 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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