Cleared Traditional

K852485 - CELLGRO(ISCOVE'S MEDIUM) MODIFICATION

K852485 is the FDA 510(k) clearance for CELLGRO(ISCOVE'S MEDIUM) MODIFICATION by Mediatech, Inc.. It is a Class 1 Pathology device (product code KIT) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K852485 · Mediatech, Inc. · Pathology device
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Jul 1985
Decision
31d
Days
Class 1
Risk

K852485 is an FDA 510(k) clearance for the CELLGRO(ISCOVE'S MEDIUM) MODIFICATION. 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 July 12, 1985 after a review of 31 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 Mediatech, Inc. devices

Submission Details

510(k) Number K852485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1985
Decision Date July 12, 1985
Days to Decision 31 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 77d · This submission: 31d
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 306
Devices cleared under the same product code (KIT) and FDA review panel - the closest regulatory comparables to K852485.
WILLIAMS MEDIUM E POWDER
K861885 · Hazleton Research Products, Inc. · May 1986
DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM
K861886 · Hazleton Research Products, Inc. · May 1986
MEM GLASGOW POWDERED MEDIUM
K861887 · Hazleton Research Products, Inc. · May 1986
MCDB 201 MED CAT NO. M6770 W/ HEPES & W0/ BICARBON
K852568 · Sigma Chemical Co. · Jul 1985
CRCM-30 MEDIUM PRODUCT NO. C5030
K851604 · Sigma Chemical Co. · May 1985
SWIN'S S-77 MEDIUM, PRODUCTS S2513
K851605 · Sigma Chemical Co. · May 1985