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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K023407
Device Name ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR
Applicant
ELAN DIAGNOSTICS
1075 W. LAMBERT RD., SUITE D
BREA,  CA  92821
Applicant Contact WYNN STOCKING
Correspondent
ELAN DIAGNOSTICS
1075 W. LAMBERT RD., SUITE D
BREA,  CA  92821
Correspondent Contact WYNN STOCKING
Regulation Number862.1225
Classification Product Code
CGX  
Subsequent Product Code
JIS  
Date Received10/10/2002
Decision Date 02/14/2003
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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