Cleared Traditional

K894518 - FPR AMIKACIN CALIBRATOR KIT
(FDA 510(k) Clearance)

K894518 · Colony Laboratories, Inc. · Toxicology

Sep 1989

Decision

70d

Days

Class 1

Risk

K894518 is an FDA 510(k) clearance for the FPR AMIKACIN CALIBRATOR KIT, a Coating, Liquid, Glc (Class I — General Controls, product code DLG), submitted by Colony Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on September 28, 1989, 70 days after receiving the submission on July 20, 1989. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2250.

Submission Details

510(k) Number	K894518 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 20, 1989
Decision Date	September 28, 1989
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—