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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K110212
Device Name INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP
Applicant
ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE
9975 Summers Ridge Road
San Diego,  CA  92121
Applicant Contact MARA CALER
Correspondent
ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE
9975 Summers Ridge Road
San Diego,  CA  92121
Correspondent Contact MARA CALER
Regulation Number864.7750
Classification Product Code
GJS  
Date Received01/25/2011
Decision Date 05/01/2012
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT00933738
NCT01037270
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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