The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Tnl-ultra Assay For The Advia Centaur System.
| Device ID | K053020 |
| 510k Number | K053020 |
| Device Name: | TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Andres Holle |
| Correspondent | Andres Holle BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-26 |
| Decision Date | 2005-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414600109 | K053020 | 000 |
| 00630414600093 | K053020 | 000 |
| 00630414516226 | K053020 | 000 |
| 00630414516219 | K053020 | 000 |
| 00630414293790 | K053020 | 000 |