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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 SOUTH KRAEMER BLVD.
M/S W-110
BREA,  CA  92822 -8000
Applicant Contact TARA VIVIANI
Correspondent
BECKMAN COULTER, INC.
200 SOUTH 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
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