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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 K002948
Device Name K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
Applicant
Kamiya Biomedical Co.
910 Industry Dr.
Seattle,  WA  98188 -3412
Applicant Contact COLIN GETTY
Correspondent
Kamiya Biomedical Co.
910 Industry Dr.
Seattle,  WA  98188 -3412
Correspondent Contact COLIN GETTY
Regulation Number864.7320
Classification Product Code
DAP  
Date Received09/21/2000
Decision Date 05/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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