Cleared Traditional

SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT

K872847 · Candace Lane Corp. · Pathology
Aug 1987
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K872847 is an FDA 510(k) clearance for the SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT, a Sera, Animal And Human (Class I — General Controls, product code KIS), submitted by Candace Lane Corp. (Parsippany, US). The FDA issued a Cleared decision on August 10, 1987, 21 days after receiving the submission on July 20, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2800.

Submission Details

510(k) Number K872847 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1987
Decision Date August 10, 1987
Days to Decision 21 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary

Device Classification

Product Code KIS — Sera, Animal And Human
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2800

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