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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K770453
Device Name PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE
Applicant
Icn Pharmaceuticals, Inc.
13 Mountainview Ave.
Orangeburg,  NY  10962
Correspondent
Icn Pharmaceuticals, Inc.
13 Mountainview Ave.
Orangeburg,  NY  10962
Regulation Number862.1050
Classification Product Code
CIO  
Date Received03/08/1977
Decision Date 05/03/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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