Cleared Traditional

K850510 - EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN

K850510 is an FDA 510(k) clearance for EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NO..., 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 24-day FDA review.

K850510 · Mediatech, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
24d
Days
Class 1
Risk

K850510 is an FDA 510(k) clearance for the EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN. 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 March 4, 1985 after a review of 24 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 - K850510

510(k) Number K850510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1985
Decision Date March 04, 1985
Days to Decision 24 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 102d · This submission: 24d
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 K850510.
WAYMOUTH'S MEDIUM MB 752/1
K850224 · Hazleton Research Products, Inc. · Mar 1985
RPMI-1603 MEDIUM
K850229 · Hazleton Research Products, Inc. · Mar 1985
RPMI-1634 MEDIUM
K850230 · Hazleton Research Products, Inc. · Mar 1985
NUTRIENT MIXTURE F-10 -HAM, N 1387, W/L-GLUTAMINE
K845012 · Sigma Chemical Co. · Feb 1985
RPMI-1640 MED. W/L-GLUTAMINE & 25MM HEPES & W/O SO
K845013 · Sigma Chemical Co. · Feb 1985
MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES
K845014 · Sigma Chemical Co. · Feb 1985