Cleared Traditional

DU PONT STERICELL CELL CULTURE SYSTEM

K871324 · E.I. Dupont DE Nemours & Co., Inc. · Pathology
Apr 1987
Decision
11d
Days
Class 1
Risk

About This 510(k) Submission

K871324 is an FDA 510(k) clearance for the DU PONT STERICELL CELL CULTURE SYSTEM, a Flask, Tissue Culture (Class I — General Controls, product code KJA), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on April 14, 1987, 11 days after receiving the submission on April 3, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.

Submission Details

510(k) Number K871324 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1987
Decision Date April 14, 1987
Days to Decision 11 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KJA — Flask, Tissue Culture
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2240

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