510(k) K151867 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
STA R MAX
| Applicant | Diagnostica Stago S.A.S, Gennevilliers, FR |
| Decision | Substantially Equivalent, Aug 7, 2015 |
| Received | Jul 9, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151867
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2023 | Diagnostica Stago, Inc. STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026 Open, Classified |
JPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.