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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 K870353
Device Name IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)
Applicant
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Applicant Contact KAREN H DARCY
Correspondent
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Correspondent Contact KAREN H DARCY
Regulation Number864.7290
Classification Product Code
GGP  
Date Received01/29/1987
Decision Date 02/10/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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