Cleared Traditional

K853690 - COLUMBIZ BLOOD AGAR
(FDA 510(k) Clearance)

K853690 · Micro Media Laboratories · Microbiology

Sep 1985

Decision

13d

Days

Class 1

Risk

K853690 is an FDA 510(k) clearance for the COLUMBIZ BLOOD AGAR. This device is classified as a Culture Media, Non-selective And Non-differential (Class I — General Controls, product code JSG).

Submitted by Micro Media Laboratories (San Diego, US). The FDA issued a Cleared decision on September 17, 1985, 13 days after receiving the submission on September 4, 1985.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2300.

Submission Details

510(k) Number	K853690 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 04, 1985
Decision Date	September 17, 1985
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—