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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 K872195
Device Name DATA-FI DIMERTEST LATEX ASSAY
Original Applicant
AMERICAN DADE
p.o. box 25101
santa ana,  CA  92799
Original Contact karen h darcy
Regulation Number864.7320
Classification Product Code
DAP  
Subsequent Product Code
GHH  
Date Received06/08/1987
Decision Date 08/06/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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