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FDA 510(k) Application Details - K161317
Device Classification Name
System, Multipurpose For In Vitro Coagulation Studies
More FDA Info for this Device
510(K) Number
K161317
Device Name
System, Multipurpose For In Vitro Coagulation Studies
Applicant
Siemens Healthcare Diagnostics Products GmbH
Emil-von-Behring-Str. 76
Marburg 35041 DE
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Contact
Nils Neumann
Other 510(k) Applications for this Contact
Regulation Number
864.5425
More FDA Info for this Regulation Number
Classification Product Code
JPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/11/2016
Decision Date
09/02/2016
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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