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510(k) K890422

ABBOTT TESTPACK(TM) D-DIMER by Abbott Laboratories — Product Code GHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1989
Date Received
January 26, 1989
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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