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 the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica Stago S.A.S. It received FDA 510(k) clearance on 2022-12-23 under 510(k) 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. The listed applicant is Diagnostica Stago S.A.S. The 510(k) number is K211485.

When did STA- NeoPTimal receive FDA 510(k) clearance?

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

Who is the listed applicant for STA- NeoPTimal?

The FDA 510(k) record lists Diagnostica Stago S.A.S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STA- NeoPTimal?

The FDA product code for STA- NeoPTimal is GJS.

Other records listing Diagnostica Stago S.A.S as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212183STA R Max 3, STA Compact Max 3

Related Devices (Code: GJS)

K253188CoaguChek XS Plus SystemRoche Diagnostics K251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott Laboratories K231711microINR 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.