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FDA 510(k)

STA Satellite Max®

K-Number: K253658 · 2026-04-27

ApplicantDiagnostica Stago, Inc.
Decision Date2026-04-27
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STA Satellite Max® 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 2026-04-27 under 510(k) number K253658. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STA Satellite Max®?

STA Satellite Max® is a medical device that received FDA 510(k) clearance on 2026-04-27. The listed applicant is Diagnostica Stago, Inc.. The 510(k) number is K253658.

When did STA Satellite Max® receive FDA 510(k) clearance?

STA Satellite Max® received FDA 510(k) clearance on 2026-04-27, under 510(k) number K253658.

Who is the listed applicant for STA Satellite Max®?

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 Satellite Max®?

The FDA product code for STA Satellite Max® is JPA.

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.

K162227STA® - Liatest® D-Di

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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.

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