The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Bayer Advia Centaur Automated Chemiluminescence Analyzer.
| Device ID | K032525 |
| 510k Number | K032525 |
| Device Name: | BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER |
| Classification | Test, Natriuretic Peptide |
| 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 | NBC |
| Subsequent Product Code | CDD |
| Subsequent Product Code | CDZ |
| Subsequent Product Code | CEC |
| Subsequent Product Code | CEP |
| Subsequent Product Code | CFT |
| Subsequent Product Code | CGJ |
| Subsequent Product Code | CGN |
| Subsequent Product Code | CHP |
| Subsequent Product Code | DBF |
| Subsequent Product Code | DDR |
| Subsequent Product Code | DGC |
| Subsequent Product Code | DHX |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DKB |
| Subsequent Product Code | GWG |
| Subsequent Product Code | JFT |
| Subsequent Product Code | JHI |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJE |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-15 |
| Decision Date | 2003-09-09 |
| Summary: | summary |