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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, C-Reactive Protein
510(k) Number K061825
Device Name DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH
Applicant
Dade Behring, Inc.
P.O. Box 6101
Newark,  DE  19714
Applicant Contact KATHLEEN DRAY-LYONS
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Newark,  DE  19714
Correspondent Contact KATHLEEN DRAY-LYONS
Regulation Number866.5270
Classification Product Code
DCN  
Subsequent Product Codes
JIX   JJY  
Date Received06/28/2006
Decision Date 09/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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