Cleared Traditional

TISSUE CULTURE FLASK PL 732 PLASTIC

K861253 · Travenol Laboratories, S.A. · Pathology
Apr 1986
Decision
8d
Days
Class 1
Risk

About This 510(k) Submission

K861253 is an FDA 510(k) clearance for the TISSUE CULTURE FLASK PL 732 PLASTIC, a Flask, Tissue Culture (Class I — General Controls, product code KJA), submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on April 11, 1986, 8 days after receiving the submission on April 3, 1986. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.

Submission Details

510(k) Number K861253 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1986
Decision Date April 11, 1986
Days to Decision 8 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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