FDA 510(k)

STA® - Liquid Anti-Xa

K-Number: K260214 · 2026-09-24

Decision Date2026-09-24

Product CodeKFF

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

STA® - Liquid Anti-Xa is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica Stago, Inc.. It received FDA 510(k) clearance on 2026-09-24 under 510(k) number K260214. The device is classified under product code KFF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STA® - Liquid Anti-Xa?

STA® - Liquid Anti-Xa is a medical device that received FDA 510(k) clearance on 2026-09-24. The listed applicant is Diagnostica Stago, Inc.. The 510(k) number is K260214.

When did STA® - Liquid Anti-Xa receive FDA 510(k) clearance?

STA® - Liquid Anti-Xa received FDA 510(k) clearance on 2026-09-24, under 510(k) number K260214.

Who is the listed applicant for STA® - Liquid Anti-Xa?

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

What is the FDA product code for STA® - Liquid Anti-Xa?

The FDA product code for STA® - Liquid Anti-Xa is KFF.

Other records listing Diagnostica Stago, Inc. 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.

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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.