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510(k) K943571

MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS by More Diagnostics — Product Code DAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1995
Date Received
July 19, 1994
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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