Cleared Traditional

EPIPACK

K880999 · Clonetics Corp. · Pathology
Mar 1988
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K880999 is an FDA 510(k) clearance for the EPIPACK, 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 24, 1988, 16 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 K880999 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 1988
Decision Date March 24, 1988
Days to Decision 16 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KIT — Media And Components, Synthetic Cell And Tissue Culture
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2220