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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Partial Thromboplastin
510(k) Number K863594
Device Name ACTIN FSL ACTIVATED PTT REAGENT
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 Number864.7925
Classification Product Code
GGW  
Date Received09/15/1986
Decision Date 10/17/1986
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
Recalls CDRH Recalls
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