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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 K021609
Device Name RDI HS CRP KIT
Applicant
Reference Diagnostics, Inc.
19 Crosby Dr. Suite 30
Bedford,  MA  01730
Applicant Contact JOSEPH LAWLOR
Correspondent
Reference Diagnostics, Inc.
19 Crosby Dr. Suite 30
Bedford,  MA  01730
Correspondent Contact JOSEPH LAWLOR
Regulation Number866.5270
Classification Product Code
DCK  
Date Received05/16/2002
Decision Date 06/27/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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