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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthotoluidine, Glucose
510(k) Number K770455
Device Name GLUCOSE PROCEDURE, TEKPOINT DIRECT
Applicant
Icn Pharmaceuticals, Inc.
13 Mountainview Ave.
Orangeburg,  NY  10962
Correspondent
Icn Pharmaceuticals, Inc.
13 Mountainview Ave.
Orangeburg,  NY  10962
Regulation Number862.1345
Classification Product Code
CGE  
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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