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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 K092987
Device Name INRATIO/INRATIO2 TEST STRIPS
Applicant
BIOSITE INCORPORATED
9975 SUMMERS RIDGE RD
SAN DIEGO,  CA  92121
Applicant Contact KARIN A HUGES
Correspondent
BIOSITE INCORPORATED
9975 SUMMERS RIDGE RD
SAN DIEGO,  CA  92121
Correspondent Contact KARIN A HUGES
Regulation Number864.7750
Classification Product Code
GJS  
Date Received09/28/2009
Decision Date 06/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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