STA Satellite Max®— 510(k) K253658

Substantially Equivalent

Diagnostica Stago, Inc.

FDA 510(k) clearance K253658 for STA Satellite Max®, Substantially Equivalent on 2026-04-27. Applicant: Diagnostica Stago, Inc..

Clearance details

Applicant: Diagnostica Stago, Inc.
Product code: Code JPA
Advisory panel: Hematology
Date received: 2025-11-20
Decision date: 2026-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.