Cleared Traditional

K850519 - GLUTAMINE-1-GLUTAMINE

K850519 is an FDA 510(k) clearance for GLUTAMINE-1-GLUTAMINE, manufactured by Mediatech, Inc.. The device is a Class 1 Microbiology device with product code KIT cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K850519 · Mediatech, Inc. · Microbiology device
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Feb 1985
Decision
19d
Days
Class 1
Risk

K850519 is an FDA 510(k) clearance for the GLUTAMINE-1-GLUTAMINE. 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 Microbiology FDA review panel, regulated under 21 CFR 864.2220 - the FDA microbiology 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 - K850519

510(k) Number K850519 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 Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 102d · 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 K850519.
HAM'S F-12-A SPEDIFIC FORMULATION FORM DR. HAM
K850516 · Mediatech, Inc. · Feb 1985
MED. 199 W/EARLE'S SALTS-MEDIUM 199 W/EARLES SALTS
K850517 · Mediatech, Inc. · Feb 1985
NA PYRUVATE-SODIUM PYRUVATE
K850518 · Mediatech, Inc. · Feb 1985
NEAA-NON-ESSENTIAL AMINO ACIDS
K850520 · Mediatech, Inc. · Feb 1985
MEM AA-MINIMUM ESSENTIAL MEDIUM AMINO ACIDS
K850521 · Mediatech, Inc. · Feb 1985
MEM VITAMINS-MINIMUM ESSENTIAL MEDIUM VITAMINS
K850522 · Mediatech, Inc. · Feb 1985