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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nadh Oxidation/Nad Reduction, Ast/Sgot
510(k) Number K010488
Device Name ATAC PAK AST REAGENT KIT
Applicant
Elan Holdings, Inc.
231 N. Puente St.
Brea,  CA  92821
Applicant Contact WYNN STOCKING
Correspondent
Elan Holdings, Inc.
231 N. Puente St.
Brea,  CA  92821
Correspondent Contact WYNN STOCKING
Regulation Number862.1100
Classification Product Code
CIT  
Date Received02/20/2001
Decision Date 04/09/2001
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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