Cleared Traditional

K883682 - CHANG MEDIUM (ADDITIONAL INDICATIONS) (FDA 510(k) Clearance)

Class I Pathology device.

K883682 · Hana Biologics, Inc. · Pathology device
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Sep 1988
Decision
18d
Days
Class 1
Risk

K883682 is an FDA 510(k) clearance for the CHANG MEDIUM (ADDITIONAL INDICATIONS). Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Hana Biologics, Inc. (Alameda, US). The FDA issued a Cleared decision on September 16, 1988 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2220 - 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 Hana Biologics, Inc. devices

Submission Details

510(k) Number K883682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1988
Decision Date September 16, 1988
Days to Decision 18 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 77d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIT Media And Components, Synthetic Cell And Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2220
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.