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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nadh Oxidation/Nad Reduction, Alt/Sgpt
510(k) Number K061020
Device Name DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
Applicant
Dade Behring, Inc.
Bldg. 500; M.S. 514
P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact LORRAINE H PIESTRAK
Correspondent
Dade Behring, Inc.
Bldg. 500; M.S. 514
P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact LORRAINE H PIESTRAK
Regulation Number862.1030
Classification Product Code
CKA  
Subsequent Product Codes
CIT   JMO   KLT  
Date Received04/13/2006
Decision Date 05/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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