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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 K811589
Device Name ACTIN FS ACTIVATED PTT REAGENT
Applicant
AMERICAN DADE
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AMERICAN DADE
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number864.7925
Classification Product Code
GGW  
Date Received06/08/1981
Decision Date 07/16/1981
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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