The following data is part of a premarket notification filed by Tem Innovations Gmbh with the FDA for Ex-tem. Fib-tem, And Ap-tem For Rotem Delta Thromboelastometry System.
| Device ID | K101533 |
| 510k Number | K101533 |
| Device Name: | EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | Tem Innovations GmbH MARTIN-KOLLAR STR 13-15 Munich, Bavaria/upper Bavaria, DE 81829 |
| Contact | Volker-joachim Friemert |
| Correspondent | Volker-joachim Friemert Tem Innovations GmbH MARTIN-KOLLAR STR 13-15 Munich, Bavaria/upper Bavaria, DE 81829 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-03 |
| Decision Date | 2011-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260160470242 | K101533 | 000 |
| 04260160470075 | K101533 | 000 |
| 04260160470068 | K101533 | 000 |