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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 K905633
Device Name HUMAN C-REACTIVE PROTEIN RID KIT
Applicant
THE BINDING SITE, LTD.
WESTSIDE TOWERS, SUITE 1000
11845 WEST OLYMPIC BLVD.
LOS ANGELES,  CA  90064
Applicant Contact JAY GELLER
Correspondent
THE BINDING SITE, LTD.
WESTSIDE TOWERS, SUITE 1000
11845 WEST OLYMPIC BLVD.
LOS ANGELES,  CA  90064
Correspondent Contact JAY GELLER
Regulation Number866.5270
Classification Product Code
DCK  
Date Received12/14/1990
Decision Date 07/22/1991
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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