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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K770312
Device Name CHEMISTRY CONTROL, ABNORMAL
Applicant
Icn Pharmaceuticals, Inc.
13 Mountainview Ave.
Orangeburg,  NY  10962
Correspondent
Icn Pharmaceuticals, Inc.
13 Mountainview Ave.
Orangeburg,  NY  10962
Regulation Number862.1660
Classification Product Code
JJY  
Date Received02/16/1977
Decision Date 04/05/1977
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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