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510(k) K042890

TRIAGE D-DIMER TEST, MODEL 98100 by Biosite Incorporated — Product Code GHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2004
Date Received
October 19, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrin Split Products
Device Class
Class II
Regulation Number
864.7320
Review Panel
HE
Submission Type

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