Cleared Traditional

K860788 - HAM'S F-12 W/GLUTAMINE & NAHCO3 (FDA 510(k) Clearance)

Class I Pathology device.

K860788 · Tissue Culture Innovations · Pathology device
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Mar 1986
Decision
9d
Days
Class 1
Risk

K860788 is an FDA 510(k) clearance for the HAM'S F-12 W/GLUTAMINE & NAHCO3. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Tissue Culture Innovations (Santa Ana, US). The FDA issued a Cleared decision on March 12, 1986 after a review of 9 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 Tissue Culture Innovations devices

Submission Details

510(k) Number K860788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1986
Decision Date March 12, 1986
Days to Decision 9 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 77d · This submission: 9d
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.