Cleared Traditional

ENDOTHELIAL GROWTH MEDIUM (EGM)

K890701 · Clonetics Corp. · Pathology

Feb 1989

Decision

14d

Days

Class 1

Risk

About This 510(k) Submission

K890701 is an FDA 510(k) clearance for the ENDOTHELIAL GROWTH MEDIUM (EGM), 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 February 24, 1989, 14 days after receiving the submission on February 10, 1989. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2220.

Submission Details

510(k) Number	K890701 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 10, 1989
Decision Date	February 24, 1989
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—