Cleared Traditional

K872847 - SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT (FDA 510(k) Clearance)

Class I Pathology device.

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

K872847 is an FDA 510(k) clearance for the SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT. Classified as Sera, Animal And Human (product code KIS), Class I - General Controls.

Submitted by Candace Lane Corp. (Parsippany, US). The FDA issued a Cleared decision on August 10, 1987 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2800 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Candace Lane Corp. devices

Submission Details

510(k) Number K872847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1987
Decision Date August 10, 1987
Days to Decision 21 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 77d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIS Sera, Animal And Human
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.