Cleared Traditional

REMEL CEFPROZIL 30 MCG SUSCEPTIBILITY DISK

K934100 · Remel Co. · Microbiology
Nov 1993
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K934100 is an FDA 510(k) clearance for the REMEL CEFPROZIL 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 November 22, 1993, 91 days after receiving the submission on August 23, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K934100 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 1993
Decision Date November 22, 1993
Days to Decision 91 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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