Cleared Traditional

DRYSLIDE CARTARRHALIS

K954783 · Difco Laboratories, Inc. · Microbiology
Feb 1996
Decision
112d
Days
Class 1
Risk

About This 510(k) Submission

K954783 is an FDA 510(k) clearance for the DRYSLIDE CARTARRHALIS, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by Difco Laboratories, Inc. (Livouia, US). The FDA issued a Cleared decision on February 6, 1996, 112 days after receiving the submission on October 17, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K954783 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 1995
Decision Date February 06, 1996
Days to Decision 112 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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