Cleared Traditional

MUG-INDOLE DISC

K874933 · Scott Laboratories, Inc. · Microbiology
Jan 1988
Decision
32d
Days
Class 1
Risk

About This 510(k) Submission

K874933 is an FDA 510(k) clearance for the MUG-INDOLE DISC, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by Scott Laboratories, Inc. (Sulphur, US). The FDA issued a Cleared decision on January 5, 1988, 32 days after receiving the submission on December 4, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K874933 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1987
Decision Date January 05, 1988
Days to Decision 32 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JTO — Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660