Cleared Traditional

K860623 - CELLGRO HEPES BUFFER SOLUTION

K860623 is an FDA 510(k) clearance for CELLGRO HEPES BUFFER SOLUTION, manufactured by Mediatech, Inc.. The device is a Class 1 Pathology device with product code KIT cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K860623 · Mediatech, Inc. · Pathology device
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Mar 1986
Decision
12d
Days
Class 1
Risk

K860623 is an FDA 510(k) clearance for the CELLGRO HEPES BUFFER SOLUTION. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Mediatech, Inc. (Herndon, US). The FDA issued a Cleared decision on March 3, 1986 after a review of 12 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.

FDA 510(k) Submission Details - K860623

510(k) Number K860623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1986
Decision Date March 03, 1986
Days to Decision 12 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 78d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

KIT Device Classification - Class 1, General Controls

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 366
Devices cleared under the same product code (KIT) and FDA review panel - the closest regulatory comparables to K860623.
RPMI 1640 HEPES
K860786 · Tissue Culture Innovations · Mar 1986
DULBECCO'S MEM
K860787 · Tissue Culture Innovations · Mar 1986
HAM'S F-12 W/GLUTAMINE & NAHCO3
K860788 · Tissue Culture Innovations · Mar 1986
RPMI 1640 W/GLUTAMINE W/HEPES
K860282 · Newport Biosystems, Inc. · Feb 1986
TISSUE CULTURE MEDIA
K855085 · Newport Biosystems, Inc. · Jan 1986
PENICILLIN/STREPTOMYCIN SOLUTION
K854567 · Mediatech, Inc. · Dec 1985
K860623 · CELLGRO HEPES BUFFER SOLUTION
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