Cleared Traditional

REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK

K933118 · Remel Co. · Microbiology
Aug 1993
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K933118 is an FDA 510(k) clearance for the REMEL CLARITHROMYCIN 15 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 August 10, 1993, 46 days after receiving the submission on June 25, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K933118 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 1993
Decision Date August 10, 1993
Days to Decision 46 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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