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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 K052591
Device Name NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
Applicant
Clinical Data, Inc.
One Gateway Center, Suite 411
Newton,  MA  02146
Applicant Contact ISRAEL M STEIN
Correspondent
Clinical Data, Inc.
One Gateway Center, Suite 411
Newton,  MA  02146
Correspondent Contact ISRAEL M STEIN
Regulation Number866.5270
Classification Product Code
DCK  
Subsequent Product Code
JIS  
Date Received09/21/2005
Decision Date 02/09/2006
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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