510(k) K083842 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
ROTEM DELTA THROMBOELASTOMETRY SYSTEM
| Applicant | Pentapharm GmbH, Munich, DE |
| Decision | Substantially Equivalent, Mar 23, 2010 |
| Received | Dec 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083842
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2016 | TEM Systems Inc ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thr Terminated |
GGN | None listed |
| Apr 3, 2015 | TEM Systems Inc ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH. Terminated |
JPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.