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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Methods, Galactose
510(k) Number K951329
Device Name IMMUCHEM GAL-MW EA
Applicant
Icn Pharmaceuticals, Inc.
3300 Hyland Ave.
Costa Mesa,  CA  92626
Applicant Contact ROBIN J HELLEN
Correspondent
Icn Pharmaceuticals, Inc.
3300 Hyland Ave.
Costa Mesa,  CA  92626
Correspondent Contact ROBIN J HELLEN
Regulation Number862.1310
Classification Product Code
JIA  
Date Received03/23/1995
Decision Date 11/09/1995
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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