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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 K012474
Device Name ATAC PAK CPK REAGENT KIT
Applicant
Elan Holdings, Inc.
1075 W. Lambert Rd.
Suite D
Brea,  CA  92821
Applicant Contact WYNN STOCKING
Correspondent
Elan Holdings, Inc.
1075 W. Lambert Rd.
Suite D
Brea,  CA  92821
Correspondent Contact WYNN STOCKING
Regulation Number862.1215
Classification Product Code
CGS  
Date Received08/02/2001
Decision Date 10/03/2001
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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