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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K040241
Device Name N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET
Applicant
Genzyme Corp.
One Kendall Sq.
Cambridge,  MA  02139
Applicant Contact FRED D LASKY
Correspondent
Genzyme Corp.
One Kendall Sq.
Cambridge,  MA  02139
Correspondent Contact FRED D LASKY
Regulation Number866.5270
Classification Product Code
DCK  
Subsequent Product Code
JIS  
Date Received02/03/2004
Decision Date 06/25/2004
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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