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510(k) K113211

HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL by Instrumentation Laboratory CO — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2012
Date Received
October 31, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Control
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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