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FDA 510(k) Application Details - K162420
Device Classification Name
System, Multipurpose For In Vitro Coagulation Studies
More FDA Info for this Device
510(K) Number
K162420
Device Name
System, Multipurpose For In Vitro Coagulation Studies
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
EMIL-VON-BEHRING STRASSE 76
Marburg 35041 DE
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Contact
PETRA DISSMANN
Other 510(k) Applications for this Contact
Regulation Number
864.5425
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Classification Product Code
JPA
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More FDA Info for this Product Code
Date Received
08/30/2016
Decision Date
12/12/2016
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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