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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
510(k) Number K962247
Device Name HICHEM CK/NAC REAGENT KIT
Applicant
Elan Pharma, Inc.
231 N. Puente St.
Brea,  CA  92621
Applicant Contact WYNN STOCKING
Correspondent
Elan Pharma, Inc.
231 N. Puente St.
Brea,  CA  92621
Correspondent Contact WYNN STOCKING
Regulation Number862.1215
Classification Product Code
CGS  
Date Received06/11/1996
Decision Date 08/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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