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.
Clearance details
- Applicant
- Diagnostica Stago, Inc.
- Product code
- 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
Recent devices under product code JPA
view allMore 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.