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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C5, Antigen, Antiserum, Control
510(k) Number K942326
Device Name HUMAN C5 RID KITS
Applicant
Jay H. Geller
2425 W. Olympic Blvd.
Suite 600
Santa Monica,  CA  90404
Applicant Contact JAY H GELLER
Correspondent
Jay H. Geller
2425 W. Olympic Blvd.
Suite 600
Santa Monica,  CA  90404
Correspondent Contact JAY H GELLER
Regulation Number866.5240
Classification Product Code
DAY  
Date Received05/13/1994
Decision Date 08/24/1995
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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