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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 K022096
Device Name URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
Applicant
Bayer Diagnostics Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact KENNETH T EDDS
Correspondent
Bayer Diagnostics Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact KENNETH T EDDS
Regulation Number862.1775
Classification Product Code
KNK  
Date Received06/27/2002
Decision Date 03/18/2003
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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