Cleared Traditional

REMEL CEFPODOXIME 10 MCG SUSCEPTIBILITY DISK

K931289 · Remel Co. · Microbiology
Jun 1993
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K931289 is an FDA 510(k) clearance for the REMEL CEFPODOXIME 10 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 2, 1993, 82 days after receiving the submission on March 12, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K931289 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 1993
Decision Date June 02, 1993
Days to Decision 82 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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