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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K853986
Device Name THROMBOPLASTIN-R REAGENT
Applicant
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Applicant Contact JAMES E KELLER
Correspondent
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Correspondent Contact JAMES E KELLER
Regulation Number864.5425
Classification Product Code
JPA  
Date Received09/27/1985
Decision Date 11/12/1985
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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