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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 K953207
Device Name HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)
Applicant
The Binding Site, Ltd.
East Tower, Suite 600
2425 W. Olympic Blvd.
Santa Monica,  CA  90404
Applicant Contact JAY GELLER
Correspondent
The Binding Site, Ltd.
East Tower, Suite 600
2425 W. Olympic Blvd.
Santa Monica,  CA  90404
Correspondent Contact JAY GELLER
Regulation Number866.5270
Classification Product Code
DCK  
Date Received05/30/1995
Decision Date 08/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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