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510(k) K881150

KINETIC FIBRINOGEN ASSAY by Bio/Data Corp. — Product Code GIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1988
Date Received
March 17, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Fibrinogen
Device Class
Class II
Regulation Number
864.7340
Review Panel
HE
Submission Type

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