Cleared Traditional

REMEL CEFMETAZOLE 30 MCG SUSCEPTIBILITY DISK

K931290 · Remel Co. · Microbiology
May 1993
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K931290 is an FDA 510(k) clearance for the REMEL CEFMETAZOLE 30 MCG 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 May 20, 1993, 69 days after receiving the submission on March 12, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K931290 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 1993
Decision Date May 20, 1993
Days to Decision 69 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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