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510(k) K071319

I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 by Bio-Rad, Diagnostics Grp. — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2007
Date Received
May 10, 2007
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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