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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Human Chorionic Gonadotropin
510(k) Number K063754
Device Name DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632
Applicant
Dade Behring, Inc.
P.O. Box 6101 Bldg. 500;M.S.514
Newark,  DE  19714 -6101
Applicant Contact PAMELA A JURGA
Correspondent
Dade Behring, Inc.
P.O. Box 6101 Bldg. 500;M.S.514
Newark,  DE  19714 -6101
Correspondent Contact PAMELA A JURGA
Regulation Number862.1155
Classification Product Code
DHA  
Subsequent Product Code
JIT  
Date Received12/19/2006
Decision Date 02/23/2007
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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