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510(k) K040437

TRIAGE PROFILER S.O.B. PANEL by Biosite Incorporated — Product Code DAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2004
Date Received
February 19, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
864.7320
Review Panel
HE
Submission Type

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