Cleared Traditional

REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK

K933657 · Remel Co. · Microbiology
Oct 1993
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K933657 is an FDA 510(k) clearance for the REMEL AZITHROMLYCIN 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 October 28, 1993, 93 days after receiving the submission on July 27, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K933657 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1993
Decision Date October 28, 1993
Days to Decision 93 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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