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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name 11-Dehydro Thromboxane B2 Kit, Urinary
510(k) Number K062025
Device Name ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136
Applicant
Corgenix, Inc.
11575 Main St. Suite 400
Broomfield,  CO  80020
Applicant Contact KIMBERLY N HASSLER
Correspondent
Corgenix, Inc.
11575 Main St. Suite 400
Broomfield,  CO  80020
Correspondent Contact KIMBERLY N HASSLER
Regulation Number864.5700
Classification Product Code
OBW  
Date Received07/18/2006
Decision Date 05/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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