Xprecia Stride Coagulation System, Xprecia System PT Controls

Test, Time, Prothrombin

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Xprecia Stride Coagulation System, Xprecia System Pt Controls.

Pre-market Notification Details

Device IDK151964
510k NumberK151964
Device Name:Xprecia Stride Coagulation System, Xprecia System PT Controls
ClassificationTest, Time, Prothrombin
Applicant SIEMENS HEALTHCARE DIAGNOSTICS 2 EDGEWATER DRIVE Norwood,  MA  02062
ContactNoor Malki
CorrespondentNoor Malki
SIEMENS HEALTHCARE DIAGNOSTICS 2 EDGEWATER DRIVE Norwood,  MA  02062
Product CodeGJS  
CFR Regulation Number864.7750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-16
Decision Date2016-09-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414170794 K151964 000
00630414034348 K151964 000
00630414025148 K151964 000
09360136000055 K151964 000

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