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510(k) K062530

TRIAGE PROTEIN C TEST by Biosite Incorporated — Product Code GGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2007
Date Received
August 29, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Qualitative And Quantitative Factor Deficiency
Device Class
Class II
Regulation Number
864.7290
Review Panel
HE
Submission Type

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  • K051787 — TRIAGE BNP TEST, MODEL 98000XR (September 22, 2005)

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