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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, Prothrombin
510(k) Number K864274
Device Name THROMBOPLASTIN.R
Applicant
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Applicant Contact KAREN DARCY
Correspondent
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Correspondent Contact KAREN DARCY
Regulation Number864.7750
Classification Product Code
GJS  
Date Received10/29/1986
Decision Date 11/13/1986
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
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