STA Satellite Max®— 510(k) K253658
Substantially EquivalentDiagnostica Stago, Inc.
FDA 510(k) clearance K253658 for STA Satellite Max®, Substantially Equivalent on 2026-04-27. Applicant: Diagnostica Stago, Inc.. Device class: 2.
Summary
Diagnostica Stago's STA Satellite Max is filed under product code JPA (System, Multipurpose For In Vitro Coagulation Studies). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 864.5425. Hematology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Diagnostica Stago filed from Parsippany, New Jersey. The record shows 158 calendar days from receipt to decision (November 20, 2025 to April 27, 2026).
Clearance details
- Applicant
- Diagnostica Stago, Inc.
- Product code
- Product code JPA
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Parsippany, NJ, US
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More clearances from Diagnostica Stago, Inc.
view allAdverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.