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510(k) K042723

TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 by Biosite Incorporated — Product Code DAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2004
Date Received
October 1, 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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