Automated Blood Coagulation Analyzer CS-2500

System, Multipurpose For In Vitro Coagulation Studies

Siemens Healthcare Diagnostic Products Gmbh

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostic Products Gmbh with the FDA for Automated Blood Coagulation Analyzer Cs-2500.

Pre-market Notification Details

Device IDK172286
510k NumberK172286
Device Name:Automated Blood Coagulation Analyzer CS-2500
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant Siemens Healthcare Diagnostic Products Gmbh Emil-von Behring Strasse 76 Marburg,  DE 35041
ContactNils Neumann
CorrespondentNils Neumann
Siemens Healthcare Diagnostic Products Gmbh Emil-von Behring Strasse 76 Marburg,  DE 35041
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-28
Decision Date2017-12-18
Summary:summary

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