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510(k) Data Aggregation
K Number
K151867Device Name
STA R MAX
Manufacturer
DIAGNOSTICA STAGO S.A.S.
Date Cleared
2015-08-07
(29 days)
Product Code
JPA
Regulation Number
864.5425Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTICA STAGO S.A.S.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STA R Max® is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Device Description
Diagnostica Stago's STA R Max® is a fully automatic clinical laboratory designed as a modification to the company's previously cleared STA-R Evolution® Expert Series analyzer (K093001). It performs tests which aid in the diagnosis of Haemostatic disorders and the monitoring of anticoagulant treatment. The device consists of a cuvette, a metal ball, three needles, oscillation amplitude detection, a light source and sensor, and software.
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