Cleared Traditional

B. CAT CONFIRM

K880694 · Scott Laboratories, Inc. · Microbiology
Jun 1988
Decision
115d
Days
Class 1
Risk

About This 510(k) Submission

K880694 is an FDA 510(k) clearance for the B. CAT CONFIRM, 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 June 16, 1988, 115 days after receiving the submission on February 22, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K880694 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 1988
Decision Date June 16, 1988
Days to Decision 115 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