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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Partial Thromboplastin
510(k) Number K903531
Device Name ANTICARDIOLIPIN ANTIBODY TEST SYSTEM
Applicant
Medical Innovations Corp.
P.O. Box 18225
Portland,  OR  97218
Applicant Contact METCALF, PH.D.
Correspondent
Medical Innovations Corp.
P.O. Box 18225
Portland,  OR  97218
Correspondent Contact METCALF, PH.D.
Regulation Number864.7925
Classification Product Code
GFO  
Date Received08/06/1990
Decision Date 01/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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