Cleared Traditional

K861887 - MEM GLASGOW POWDERED MEDIUM

K861887 is an FDA 510(k) clearance for MEM GLASGOW POWDERED MEDIUM, manufactured by Hazleton Research Products, Inc.. The device is a Class 1 Pathology device with product code KIT cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K861887 · Hazleton Research Products, Inc. · Pathology device
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May 1986
Decision
13d
Days
Class 1
Risk

K861887 is an FDA 510(k) clearance for the MEM GLASGOW POWDERED MEDIUM. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Hazleton Research Products, Inc. (Denver, US). The FDA issued a Cleared decision on May 29, 1986 after a review of 13 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 Hazleton Research Products, Inc. devices

FDA 510(k) Submission Details - K861887

510(k) Number K861887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1986
Decision Date May 29, 1986
Days to Decision 13 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
64d faster than avg
Panel avg: 77d · This submission: 13d
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 K861887.
RPMI-1640 MEDIUM WITH 25MM HEPES BUFFER
K861875 · Hazleton Research Products, Inc. · May 1986
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
CELLGRO HEPES BUFFER SOLUTION
K860623 · Mediatech, Inc. · Mar 1986
PENICILLIN/STREPTOMYCIN SOLUTION
K854567 · Mediatech, Inc. · Dec 1985
CELLGRO WILLIAMS' MEDIUM E
K852475 · Mediatech, Inc. · Jul 1985