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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K062530
Device Name TRIAGE PROTEIN C TEST
Applicant
Biosite Incorporated
9975 Summers Ridge Rd.
San Deigo,  CA  92121
Applicant Contact FIL V BUENVIAJE
Correspondent
Biosite Incorporated
9975 Summers Ridge Rd.
San Deigo,  CA  92121
Correspondent Contact FIL V BUENVIAJE
Regulation Number864.7290
Classification Product Code
GGP  
Date Received08/29/2006
Decision Date 01/29/2007
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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