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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 K072658
Device Name ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
Applicant
Siemens Medical Solutions Diagnostics
511 Benedict Ave.
New York,  NY  10591
Applicant Contact PHILIP LIU
Correspondent
Siemens Medical Solutions Diagnostics
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact PHILIP LIU
Regulation Number866.5270
Classification Product Code
DCN  
Subsequent Product Code
JIX  
Date Received09/20/2007
Decision Date 04/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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