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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urease And Glutamic Dehydrogenase, Urea Nitrogen
510(k) Number K021385
Device Name ATAC PAK BUN REAGENT
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 Number862.1770
Classification Product Code
CDQ  
Date Received05/02/2002
Decision Date 07/12/2002
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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