Cleared Traditional

TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD

K862152 · Travenol Laboratories, S.A. · Pathology
Jun 1986
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K862152 is an FDA 510(k) clearance for the TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD, 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 June 16, 1986, 13 days after receiving the submission on June 3, 1986. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.

Submission Details

510(k) Number K862152 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 1986
Decision Date June 16, 1986
Days to Decision 13 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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