Cleared Traditional

REMEL CEFACLOR 30MCG SUSCEPTIBILITY DISK

K924846 · Remel Co. · Microbiology
Nov 1992
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K924846 is an FDA 510(k) clearance for the REMEL CEFACLOR 30MCG 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 November 30, 1992, 63 days after receiving the submission on September 28, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K924846 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 1992
Decision Date November 30, 1992
Days to Decision 63 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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