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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
510(k) Number K012755
Device Name AUTODIMER ASSAY MODEL # 1431
Applicant
Xtrana, Inc.
6025 Nicolle St.
Ventura,  CA 
Applicant Contact PATRICK J O'LEARY
Correspondent
Xtrana, Inc.
6025 Nicolle St.
Ventura,  CA 
Correspondent Contact PATRICK J O'LEARY
Regulation Number864.7320
Classification Product Code
DAP  
Date Received08/16/2001
Decision Date 03/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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