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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
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