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510(k) K110212

INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP by Alere San Diego, Inc (Formally Biosite Incorporate — Product Code GJS

Clearance Details

Decision
SESU ()
Decision Date
May 1, 2012
Date Received
January 25, 2011
Clearance Type
Traditional
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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