Sysmex Automated Blood Coagulation Analyzer CS-5100

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 Sysmex Automated Blood Coagulation Analyzer Cs-5100.

Pre-market Notification Details

Device IDK150678
510k NumberK150678
Device Name:Sysmex Automated Blood Coagulation Analyzer CS-5100
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant Siemens Healthcare Diagnostic Products Gmbh EMIL-VON-BEHRING-STR. 76 Marburg,  DE 35041
ContactDonna Noeh
CorrespondentDonna Noeh
SIEMENS HEALTHCARE DISGNOSTICS PRODUCTS GMBH EMIL-VON-BEHRING-STR. 76 Marburg,  DE 35041
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-16
Decision Date2016-01-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987562425426 K150678 000

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