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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 K002528
Device Name SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION
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 Received08/16/2000
Decision Date 08/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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