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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 K984141
Device Name GBACT + KIT
Applicant
SIENCO, INC.
4892 VAN GORDON ST., UNIT 203
WHEATRIDGE,  CO  80033
Applicant Contact BARBARA DEBIASE
Correspondent
SIENCO, INC.
4892 VAN GORDON ST., UNIT 203
WHEATRIDGE,  CO  80033
Correspondent Contact BARBARA DEBIASE
Regulation Number864.7140
Classification Product Code
JBP  
Date Received11/18/1998
Decision Date 05/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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