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510(k) K002642

MINIQUANT D-DIMER, MODEL 1447 by Biopool Intl., Inc. — Product Code DAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2001
Date Received
August 24, 2000
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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