FDA 510(k)

STA- NeoPTimal

K-Number: K211485 · 2022-12-23

Decision Date2022-12-23

Product CodeGJS

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

STA- NeoPTimal is a medical device manufactured by Diagnostica Stago S.A.S. It received FDA 510(k) clearance on 2022-12-23 under approval number K211485. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STA- NeoPTimal?

STA- NeoPTimal is a medical device that received FDA 510(k) clearance on 2022-12-23. It is manufactured by Diagnostica Stago S.A.S. The 510(k) number is K211485.

When was STA- NeoPTimal approved by the FDA?

STA- NeoPTimal received FDA 510(k) clearance on 2022-12-23, under approval number K211485.

What company makes STA- NeoPTimal?

STA- NeoPTimal is manufactured by Diagnostica Stago S.A.S.

What is the FDA product code for STA- NeoPTimal?

The FDA product code for STA- NeoPTimal is GJS.

Other Devices by Diagnostica Stago S.A.S

K212183STA R Max 3, STA Compact Max 3

Related Devices (Code: GJS)

K151964Xprecia Stride Coagulation System, Xprecia System PT ControlsSiemens Healthcare Diagnostics K170960CoaguChek Vantus SystemRoche Diagnostics K180684CoaguChek XS Plus SystemRoche Diagnostics K180693CoaguChek XS Pro SystemRoche Diagnostics K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc. K180780microINR SystemIline Microsystems, S.L.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.