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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 K854376
Device Name HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS
Applicant
Hemotec, Inc.
14 Codding Rd.
Attleboro,  MA  02703
Applicant Contact WILLIAM A MORTON
Correspondent
Hemotec, Inc.
14 Codding Rd.
Attleboro,  MA  02703
Correspondent Contact WILLIAM A MORTON
Regulation Number864.5425
Classification Product Code
JPA  
Date Received10/30/1985
Decision Date 12/04/1985
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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