Cleared Traditional

K812820 - CHANG MEDIUM

K812820 is the FDA 510(k) clearance for CHANG MEDIUM by Hana Biologics, Inc.. It is a Class 1 Pathology device (product code KIT) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K812820 · Hana Biologics, Inc. · Pathology device
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Nov 1981
Decision
34d
Days
Class 1
Risk

K812820 is an FDA 510(k) clearance for the CHANG MEDIUM. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Hana Biologics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 10, 1981 after a review of 34 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 K812820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1981
Decision Date November 10, 1981
Days to Decision 34 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 77d · This submission: 34d
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.

Regulatory Peers - KIT Media And Components, Synthetic Cell And Tissue Culture

All 305
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