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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 K915203
Device Name D-DIMER WELLCOTEST (HA10)
Applicant
Wellcome Diagnostics
3030 Cornwallis Rd.
Research Triangle Pk,  NC  27709
Applicant Contact KAFADER II
Correspondent
Wellcome Diagnostics
3030 Cornwallis Rd.
Research Triangle Pk,  NC  27709
Correspondent Contact KAFADER II
Regulation Number864.7320
Classification Product Code
DAP  
Date Received11/18/1991
Decision Date 01/31/1992
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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