510(k) K093167 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
| Applicant | Diagnostica Stago, Inc., Parisppany NJ, US |
| Decision | Substantially Equivalent, Dec 22, 2009 |
| Received | Oct 7, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093167
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2023 | Diagnostica Stago, Inc. STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612 Open, Classified |
JPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.