Cleared Traditional

KERATINOCYTE GROWTH MEDIUM (KGM)

K881000 · Clonetics Corp. · Pathology

Mar 1988

Decision

13d

Days

Class 1

Risk

About This 510(k) Submission

K881000 is an FDA 510(k) clearance for the KERATINOCYTE GROWTH MEDIUM (KGM), a Media And Components, Synthetic Cell And Tissue Culture (Class I — General Controls, product code KIT), submitted by Clonetics Corp. (San Diego, US). The FDA issued a Cleared decision on March 21, 1988, 13 days after receiving the submission on March 8, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2220.

Submission Details

510(k) Number	K881000 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 1988
Decision Date	March 21, 1988
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—