Cleared Traditional

K770746 - PANEL, IDENTIFICATION, STREP, MICRO-ID (FDA 510(k) Clearance)

K770746 · Micro-Media Systems, Inc. · Microbiology device

Jun 1977

Decision

62d

Days

Class 1

Risk

K770746 is an FDA 510(k) clearance for the PANEL, IDENTIFICATION, STREP, MICRO-ID. This device is classified as a Culture Media, Multiple Biochemical Test (Class I - General Controls, product code JSE).

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 FDA review panel. Regulated under 21 CFR 866.2320.

Submission Details

510(k) Number	K770746 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 22, 1977
Decision Date	June 23, 1977
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—