Cleared Traditional

BACTICARD E. COLI

K934986 · Remel Co. · Microbiology
Feb 1994
Decision
127d
Days
Class 1
Risk

About This 510(k) Submission

K934986 is an FDA 510(k) clearance for the BACTICARD E. COLI, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on February 23, 1994, 127 days after receiving the submission on October 19, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K934986 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 1993
Decision Date February 23, 1994
Days to Decision 127 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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