FDA.report

510(k) K211485

Device
STA- NeoPTimal
Applicant
Diagnostica Stago S.A.S
510(k) number
K211485
Product code
GJS
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-23
Date received
2021-05-13
Regulation
864.7750
Classification name
Test, Time, Prothrombin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Pauline Vasselon
Address
3 Allée Thérésa Asniéres Sur Seine FR 92600 92600

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K180780microINR SystemIline Microsystems, S.L.2019-01-25
K180693CoaguChek XS Pro SystemRoche Diagnostics2018-04-19
K180684CoaguChek XS Plus SystemRoche Diagnostics2018-04-19
K170960CoaguChek Vantus SystemRoche Diagnostics2017-12-25
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