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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Whole Blood Clotting Time
510(k) Number K843459
Device Name HEMOTEC ACT I SYSTEM
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 Number864.7140
Classification Product Code
JBP  
Date Received09/05/1984
Decision Date 12/12/1984
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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