Cleared Traditional

PANEL, GNF, MICRO-ID

K770745 · Micro-Media Systems, Inc. · Microbiology
Jun 1977
Decision
62d
Days
Class 1
Risk

About This 510(k) Submission

K770745 is an FDA 510(k) clearance for the PANEL, GNF, MICRO-ID, a Kit, Identification, Glucose Nonfermenter (Class I — General Controls, product code JSW), submitted by Micro-Media Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 23, 1977, 62 days after receiving the submission on April 22, 1977. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K770745 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1977
Decision Date June 23, 1977
Days to Decision 62 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSW — Kit, Identification, Glucose Nonfermenter
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660