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FDA 510(k) Application Details - K151964
Device Classification Name
Test, Time, Prothrombin
More FDA Info for this Device
510(K) Number
K151964
Device Name
Test, Time, Prothrombin
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
2 EDGEWATER DRIVE
NORWOOD, MA 02062 US
Other 510(k) Applications for this Company
Contact
NOOR MALKI
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
07/16/2015
Decision Date
09/30/2016
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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