510(k) K082248 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
| Applicant | Diagnostica Stago, Inc., Parisppany NJ, US |
| Decision | Substantially Equivalent, Dec 12, 2008 |
| Received | Aug 8, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082248
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2025 | Diagnostica Stago, Inc. 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 immunologi Open, Classified |
JPA | None listed |
| Nov 6, 2012 | Diagnostica Stago, Inc. 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 Terminated |
JPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.