Cleared Traditional

K905666 - M. CAT. BUTYRATE DISC
(FDA 510(k) Clearance)

K905666 · Carr-Scarborough Microbiologicals, Inc. · Microbiology
Feb 1991
Decision
70d
Days
Class 1
Risk

K905666 is an FDA 510(k) clearance for the M. CAT. BUTYRATE DISC, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by Carr-Scarborough Microbiologicals, Inc. (Stone Mountain, US). The FDA issued a Cleared decision on February 26, 1991, 70 days after receiving the submission on December 18, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K905666 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1990
Decision Date February 26, 1991
Days to Decision 70 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