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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 K042723
Device Name TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300
Applicant
Biosite Incorporated
11030 Roselle St.
San Diego,  CA  92121
Applicant Contact JERRREY R DAHLEN
Correspondent
Biosite Incorporated
11030 Roselle St.
San Diego,  CA  92121
Correspondent Contact JERRREY R DAHLEN
Regulation Number864.7320
Classification Product Code
DAP  
Subsequent Product Codes
DDR   JHX   MMI   NBC  
Date Received10/01/2004
Decision Date 12/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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