STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER— 510(k) K082248
Substantially EquivalentDiagnostica Stago, Inc.
FDA 510(k) clearance K082248 for STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER, Substantially Equivalent on 2008-12-12. 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
- Parisppany, 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 →
Recalls naming K082248
K-number listed on FDA's recall record- Z-2473-2025 — STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.
- Z-0252-2013 — STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082248.
Data sourced from openFDA. This site is unofficial and independent of the FDA.