Cleared Traditional

K801547 - TEST PANEL FOR PRESUMP. ID/BACT. ORG
(FDA 510(k) Clearance)

K801547 · Micro-Media Systems, Inc. · Microbiology

Sep 1980

Decision

64d

Days

Class 1

Risk

K801547 is an FDA 510(k) clearance for the TEST PANEL FOR PRESUMP. ID/BACT. ORG, a Kit, Anaerobic Identification (Class I — General Controls, product code JSP), submitted by Micro-Media Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1980, 64 days after receiving the submission on July 7, 1980. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K801547 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 1980
Decision Date	September 09, 1980
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—