Cleared Traditional

K894518 - FPR AMIKACIN CALIBRATOR KIT

K894518 is an FDA 510(k) clearance for FPR AMIKACIN CALIBRATOR KIT, manufactured by Colony Laboratories, Inc.. The device is a Class 1 Toxicology device with product code DLG cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K894518 · Colony Laboratories, Inc. · Toxicology device
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Sep 1989
Decision
70d
Days
Class 1
Risk

K894518 is an FDA 510(k) clearance for the FPR AMIKACIN CALIBRATOR KIT. Classified as Coating, Liquid, Glc (product code DLG), Class I - General Controls.

Submitted by Colony Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on September 28, 1989 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2250 - the FDA toxicology 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 Colony Laboratories, Inc. devices

FDA 510(k) Submission Details - K894518

510(k) Number K894518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date September 28, 1989
Days to Decision 70 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 87d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

DLG Device Classification - Class 1, General Controls

Product Code DLG Coating, Liquid, Glc
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2250
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 - DLG Coating, Liquid, Glc

Devices cleared under the same product code (DLG) and FDA review panel - the closest regulatory comparables to K894518.
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