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510(k) K983178

COAMATIC HEPARIN by Instrumentation Laboratory CO — Product Code KFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1998
Date Received
September 11, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Heparin
Device Class
Class II
Regulation Number
864.7525
Review Panel
HE
Submission Type

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  • K013637 — ACTICHROME HEPARIN (ANTI-FIIA) (April 16, 2002)
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