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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Uric, Uricase (Colorimetric)
510(k) Number K031044
Device Name ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
Applicant
Clinical Data, Inc.
1075 W. Lambert Rd.
Bldg. D
Brea,  CA  92821
Applicant Contact WYNN STOCKING
Correspondent
Clinical Data, Inc.
1075 W. Lambert Rd.
Bldg. D
Brea,  CA  92821
Correspondent Contact WYNN STOCKING
Regulation Number862.1775
Classification Product Code
KNK  
Subsequent Product Code
JIX  
Date Received04/01/2003
Decision Date 07/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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