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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 K902081
Device Name CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL
Applicant
Hemotec, Inc.
7103 S. Revere Pkwy.
Englewood,  CO  80112
Applicant Contact BAUGH, PHD
Correspondent
Hemotec, Inc.
7103 S. Revere Pkwy.
Englewood,  CO  80112
Correspondent Contact BAUGH, PHD
Regulation Number864.7140
Classification Product Code
JBP  
Date Received05/08/1990
Decision Date 07/03/1990
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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