Cleared Traditional

K850512 - DMEM-DULBECCO'S MINIMUM ESSENTIAL MEDIUM

K850512 is an FDA 510(k) clearance for DMEM-DULBECCO'S MINIMUM ESSENTIAL MEDIUM, 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 19-day FDA review.

K850512 · Mediatech, Inc. · Pathology device
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Feb 1985
Decision
19d
Days
Class 1
Risk

K850512 is an FDA 510(k) clearance for the DMEM-DULBECCO'S MINIMUM ESSENTIAL MEDIUM. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Mediatech, Inc. (Washington, US). The FDA issued a Cleared decision on February 27, 1985 after a review of 19 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

FDA 510(k) Submission Details - K850512

510(k) Number K850512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1985
Decision Date February 27, 1985
Days to Decision 19 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
58d faster than avg
Panel avg: 77d · This submission: 19d
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 335
Devices cleared under the same product code (KIT) and FDA review panel - the closest regulatory comparables to K850512.
BASAL MED. EAGLE(BME) W/EARLE'S SALTS, L-GLUTAMINE
K850091 · Sigma Chemical Co. · Feb 1985
DULBECCO'S MODIFIED EAGLE'S MED. (DME) W/GLUCOSE A
K850092 · Sigma Chemical Co. · Feb 1985
EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA
K850511 · Mediatech, Inc. · Feb 1985
RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640
K850513 · Mediatech, Inc. · Feb 1985
ALPHA MEM-ALPHA MINIMUM ESSENTIAL MED. W/O RIBOSID
K850514 · Mediatech, Inc. · Feb 1985
HAM'S F-10-A SPEC. FORMULATION FROM DR. HAM
K850515 · Mediatech, Inc. · Feb 1985