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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 K102568
Device Name URIC ACID MODEL 3P39
Applicant
Abbott Laboratories
1921 Hurd Dr.
Irving,  TX  75038
Applicant Contact LINDA K MORRIS
Correspondent
Abbott Laboratories
1921 Hurd Dr.
Irving,  TX  75038
Correspondent Contact LINDA K MORRIS
Regulation Number862.1775
Classification Product Code
KNK  
Date Received09/07/2010
Decision Date 05/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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