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FDA 510(k) Application Details - K093460
Device Classification Name
Test, Time, Prothrombin
More FDA Info for this Device
510(K) Number
K093460
Device Name
Test, Time, Prothrombin
Applicant
Roche Diagnostics
9115 HAGUE ROAD
INDIANAPOLIS, IN 46250-0416 US
Other 510(k) Applications for this Company
Contact
JENNIFER TRIBBETT
Other 510(k) Applications for this Contact
Regulation Number
864.7750
More FDA Info for this Regulation Number
Classification Product Code
GJS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/06/2009
Decision Date
03/18/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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