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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 K032952
Device Name AIACT KIT
Applicant
Sienco, Inc.
11485-A W. 48th Ave.
Boulder,  CO  80033
Applicant Contact BARBARA DEBIASE
Correspondent
Sienco, Inc.
11485-A W. 48th Ave.
Boulder,  CO  80033
Correspondent Contact BARBARA DEBIASE
Regulation Number864.7140
Classification Product Code
JBP  
Date Received09/22/2003
Decision Date 12/12/2003
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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