Cleared Traditional

K861869 - GENTAMICIN-50MG/ML

K861869 is the FDA 510(k) clearance for GENTAMICIN-50MG/ML by Hazleton Research Products, Inc.. It is a Class 1 Pathology device (product code KIT) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K861869 · Hazleton Research Products, Inc. · Pathology device
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May 1986
Decision
14d
Days
Class 1
Risk

K861869 is an FDA 510(k) clearance for the GENTAMICIN-50MG/ML. 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 14 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

Submission Details

510(k) Number K861869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1986
Decision Date May 29, 1986
Days to Decision 14 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
63d faster than avg
Panel avg: 77d · This submission: 14d
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 304
Devices cleared under the same product code (KIT) and FDA review panel - the closest regulatory comparables to K861869.
DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM
K861996 · Hazleton Research Products, Inc. · Jun 1986
MEM ALPHA EAGLE MEDIUM
K861867 · Hazleton Research Products, Inc. · May 1986
WILLIAMS MEDIUM E
K861868 · Hazleton Research Products, Inc. · May 1986
DULBECCO'S MODIFIED EAGLE MED. W/25MM HEPES BUFFER
K861870 · Hazleton Research Products, Inc. · May 1986
NCTC 109 MEDIUM
K861871 · Hazleton Research Products, Inc. · May 1986
ISCOVE'S (MODIFIED) DULBECCO'S MEDIUM
K861872 · Hazleton Research Products, Inc. · May 1986