Cleared Traditional

K791991 - STREP-SPEC
(FDA 510(k) Clearance)

K791991 · Micro-Media Systems, Inc. · Microbiology

Nov 1979

Decision

41d

Days

Class 1

Risk

K791991 is an FDA 510(k) clearance for the STREP-SPEC. This device is classified as a Kit, Identification, Enterobacteriaceae (Class I — General Controls, product code JSS).

Submitted by Micro-Media Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979, 41 days after receiving the submission on October 3, 1979.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K791991 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 03, 1979
Decision Date	November 13, 1979
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—