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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrin Split Products
510(k) Number K021877
Device Name MDA D-DIMER
Applicant
bioMerieux, Inc.
100 Rodolphe St.
Durham,  NC  27712
Applicant Contact RON SANYAL
Correspondent
bioMerieux, Inc.
100 Rodolphe St.
Durham,  NC  27712
Correspondent Contact RON SANYAL
Regulation Number864.7320
Classification Product Code
GHH  
Date Received06/07/2002
Decision Date 08/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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