Cleared Traditional

BACTICARD STREP

K933514 · Remel Co. · Microbiology
Oct 1993
Decision
100d
Days
Class 1
Risk

About This 510(k) Submission

K933514 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 October 28, 1993, 100 days after receiving the submission on July 20, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K933514 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1993
Decision Date October 28, 1993
Days to Decision 100 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