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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name complement c1q, antigen, antiserum, control
510(k) Number K914388
Device Name C1 RID KIT
Applicant
THE BINDING SITE, LTD.
WESTSIDE TOWERS, SUITE 1000
11845 WEST OLYMPIC BLVD.
LOS ANGELES,  CA  90064
Applicant Contact JAY H GELLER
Correspondent
THE BINDING SITE, LTD.
WESTSIDE TOWERS, SUITE 1000
11845 WEST OLYMPIC BLVD.
LOS ANGELES,  CA  90064
Correspondent Contact JAY H GELLER
Regulation Number866.5240
Classification Product Code
DAK  
Date Received10/01/1991
Decision Date 10/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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