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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
510(k) Number K971658
Device Name MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT
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 Number866.5660
Classification Product Code
DBL  
Date Received04/14/1997
Decision Date 05/23/1997
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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