EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM— 510(k) K101533
Substantially EquivalentTem Innovations GmbH
FDA 510(k) clearance K101533 for EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM, Substantially Equivalent on 2011-08-10. Applicant: Tem Innovations GmbH. Device class: 2.
Clearance details
- Applicant
- Tem Innovations GmbH
- Product code
- Code JPA
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Munich, Bavaria/Upper Bavaria, DE
Recent devices under product code JPA
view allMore clearances from Tem Innovations GmbH
view allAdverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K101533
K-number listed on FDA's recall record- Z-2485-2019 — ROTEM ex-tem; US Part No: 503-05-US
- Z-2486-2019 — ROTEM ex-tem Canada Part No: 503-05-CA
- Z-2487-2019 — ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
- Z-0302-2017 — 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 delta.
- Z-1379-2015 — ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101533.
Data sourced from openFDA. This site is unofficial and independent of the FDA.