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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 K013787
Device Name NYCOCARD CRP
Applicant
Primus Corp.
P.O. Box 22599
Kansas City,  MO  64114
Applicant Contact JIMMIE K NOFFSINGER
Correspondent
Primus Corp.
P.O. Box 22599
Kansas City,  MO  64114
Correspondent Contact JIMMIE K NOFFSINGER
Regulation Number866.5270
Classification Product Code
DCK  
Date Received11/14/2001
Decision Date 05/14/2002
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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