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510(k) K132722

HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) by Instrumentation Laboratory CO — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2014
Date Received
August 30, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Prothrombin
Device Class
Class II
Regulation Number
864.7750
Review Panel
HE
Submission Type

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