Cleared Traditional

TISSUE CULTURE BAG

K870865 · American Fluoroseal Corp. · Pathology

Mar 1987

Decision

27d

Days

Class 1

Risk

About This 510(k) Submission

K870865 is an FDA 510(k) clearance for the TISSUE CULTURE BAG, a Flask, Tissue Culture (Class I — General Controls, product code KJA), submitted by American Fluoroseal Corp. (Silver Spring, US). The FDA issued a Cleared decision on March 30, 1987, 27 days after receiving the submission on March 3, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.

Submission Details

510(k) Number	K870865 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 1987
Decision Date	March 30, 1987
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—