Cleared Traditional

K872956 - SORBITOL MACCONKEY AGAR NO. 3 CM 813
(FDA 510(k) Clearance)

K872956 · Oxoid U.S.A., Inc. · Microbiology

Aug 1987

Decision

12d

Days

Class 1

Risk

K872956 is an FDA 510(k) clearance for the SORBITOL MACCONKEY AGAR NO. 3 CM 813, a Culture Media, Selective And Differential (Class I — General Controls, product code JSI), submitted by Oxoid U.S.A., Inc. (Columbia, US). The FDA issued a Cleared decision on August 10, 1987, 12 days after receiving the submission on July 29, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number	K872956 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 1987
Decision Date	August 10, 1987
Days to Decision	12 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—