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FDA 510(k) Application Details - K060978
Device Classification Name
Test, Time, Prothrombin
More FDA Info for this Device
510(K) Number
K060978
Device Name
Test, Time, Prothrombin
Applicant
Roche Diagnostics
9115 HAGUE ROAD
INDIANAP0LIS, IN 46256 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
04/10/2006
Decision Date
08/11/2006
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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