Cleared Traditional

K881287 - ANIMAL AND HUMAN SERA (FDA 510(k) Clearance)

Class I Pathology device.

K881287 · Cell Culture Laboratories · Pathology device
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Apr 1988
Decision
8d
Days
Class 1
Risk

K881287 is an FDA 510(k) clearance for the ANIMAL AND HUMAN SERA. Classified as Sera, Animal And Human (product code KIS), Class I - General Controls.

Submitted by Cell Culture Laboratories (Cleveland, US). The FDA issued a Cleared decision on April 5, 1988 after a review of 8 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.

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Submission Details

510(k) Number K881287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1988
Decision Date April 05, 1988
Days to Decision 8 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 77d · This submission: 8d
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.