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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescence Polarization Immunoassay, Theophylline
510(k) Number K894529
Device Name FPR THEOPHYLLINE 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 Number862.3880
Classification Product Code
LGS  
Date Received07/20/1989
Decision Date 09/15/1989
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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