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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coating, Liquid, Glc
510(k) Number K894528
Device Name FPR PHENYTOIN CALIBRATOR 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 Number862.2250
Classification Product Code
DLG  
Date Received07/20/1989
Decision Date 09/25/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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