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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K950015
Device Name HUMAN PROTEIN C RID 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 Number864.7290
Classification Product Code
GGP  
Date Received01/03/1995
Decision Date 03/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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