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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K071002
Device Name IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd.
M/S W-110
Brea,  CA  92822 -8000
Applicant Contact TARA VIVIANI
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd.
M/S W-110
Brea,  CA  92822 -8000
Correspondent Contact TARA VIVIANI
Regulation Number866.5270
Classification Product Code
NQD  
Subsequent Product Code
JIX  
Date Received04/09/2007
Decision Date 06/21/2007
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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