Cleared Traditional

REMEL LORACARBEF 30 MCG SUSCEPTIBILITY DISK

K931799 · Remel Co. · Microbiology
Jun 1993
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K931799 is an FDA 510(k) clearance for the REMEL LORACARBEF 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 June 15, 1993, 64 days after receiving the submission on April 12, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K931799 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1993
Decision Date June 15, 1993
Days to Decision 64 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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