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510(k) K082859

HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED by Instrumentation Laboratory CO — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2008
Date Received
September 29, 2008
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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