Cleared Traditional

K823738 - GRAM NEGATIVE BACTERIAL IDENTIF- PANELS
(FDA 510(k) Clearance)

K823738 · Micro-Media Systems, Inc. · Microbiology
Jan 1983
Decision
25d
Days
Class 1
Risk

K823738 is an FDA 510(k) clearance for the GRAM NEGATIVE BACTERIAL IDENTIF- PANELS, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by Micro-Media Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1983, 25 days after receiving the submission on December 13, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K823738 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 1982
Decision Date January 07, 1983
Days to Decision 25 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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