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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
Recalls CDRH Recalls
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