510(k) K101533 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM
| Applicant | Tem Innovations GmbH, Munich, Bavaria/Upper Bavaria, DE |
| Decision | Substantially Equivalent, Aug 10, 2011 |
| Received | Jun 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101533
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2019 | Instrumentation Laboratory Co. ROTEM ex-tem;
US Part No: 503-05-US Terminated |
JPA | None listed |
| Jul 23, 2019 | Instrumentation Laboratory Co. ROTEM ex-tem
Canada Part No: 503-05-CA Terminated |
JPA | None listed |
| Jul 23, 2019 | Instrumentation Laboratory Co. ROTEM ex-tem
Rest of the world part No: 503-05 (ROW) Terminated |
JPA | None listed |
| Sep 13, 2016 | TEM Systems Inc ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem.
Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM Terminated |
JPA | 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.