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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescent Immunoassay Gentamicin
510(k) Number K894523
Device Name FPR GENTAMICIN KIT
Applicant
Colony Laboratories, Inc.
1220 Nineteenth St., NW
Fourth Floor
Washington,  DC  20036
Applicant Contact DALE B HINSON
Correspondent
Colony Laboratories, Inc.
1220 Nineteenth St., NW
Fourth Floor
Washington,  DC  20036
Correspondent Contact DALE B HINSON
Regulation Number862.3450
Classification Product Code
LCQ  
Date Received07/20/1989
Decision Date 09/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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