Cleared Traditional

BACTIDROP(TM) MUCAP

K930878 · Remel Co. · Microbiology
May 1993
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K930878 is an FDA 510(k) clearance for the BACTIDROP(TM) MUCAP, 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 11, 1993, 81 days after receiving the submission on February 19, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K930878 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1993
Decision Date May 11, 1993
Days to Decision 81 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