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 a medical device manufactured by Diagnostica Stago, Inc.. It received FDA 510(k) clearance on 2026-04-27 under approval 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. It is manufactured by Diagnostica Stago, Inc.. The 510(k) number is K253658.
When was STA Satellite Max® approved by the FDA?
STA Satellite Max® received FDA 510(k) clearance on 2026-04-27, under approval number K253658.
What company makes STA Satellite Max®?
STA Satellite Max® is manufactured by Diagnostica Stago, Inc..
What is the FDA product code for STA Satellite Max®?
The FDA product code for STA Satellite Max® is JPA.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.