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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Control
510(k) Number K062840
Device Name TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
Applicant
Biosite Incorporated
9975 Summers Ridge Rd.
San Diego,  CA  92121
Applicant Contact FIL V BUENVIAJE
Correspondent
Biosite Incorporated
9975 Summers Ridge Rd.
San Diego,  CA  92121
Correspondent Contact FIL V BUENVIAJE
Regulation Number864.5425
Classification Product Code
GGN  
Date Received09/22/2006
Decision Date 03/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
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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