Cleared Traditional

BACTICARD STREP

K936021 · Remel Co. · Microbiology
May 1994
Decision
154d
Days
Class 1
Risk

About This 510(k) Submission

K936021 is an FDA 510(k) clearance for the BACTICARD STREP, 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 May 20, 1994, 154 days after receiving the submission on December 17, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K936021 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 1993
Decision Date May 20, 1994
Days to Decision 154 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