Cleared Traditional

CORNING CELL WELLS-MULTIPLE WELL PLATES

K853634 · Corning Medical & Scientific · Pathology
Sep 1985
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K853634 is an FDA 510(k) clearance for the CORNING CELL WELLS-MULTIPLE WELL PLATES, a Dish, Tissue Culture (Class I — General Controls, product code KIZ), submitted by Corning Medical & Scientific (Oneonta, US). The FDA issued a Cleared decision on September 16, 1985, 17 days after receiving the submission on August 30, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.

Submission Details

510(k) Number K853634 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 1985
Decision Date September 16, 1985
Days to Decision 17 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KIZ — Dish, Tissue Culture
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2240

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