The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Modification To Bayer Advia Centaur Automated Chemiluminescence Analyzer.
| Device ID | K041133 |
| 510k Number | K041133 |
| Device Name: | MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER |
| Classification | Radioassay, Vitamin B12 |
| 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 | CDD |
| Subsequent Product Code | CDP |
| Subsequent Product Code | CDZ |
| Subsequent Product Code | CEC |
| Subsequent Product Code | CEP |
| Subsequent Product Code | CEW |
| Subsequent Product Code | CFT |
| Subsequent Product Code | CGJ |
| Subsequent Product Code | CGN |
| Subsequent Product Code | DDR |
| Subsequent Product Code | DGC |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DKB |
| Subsequent Product Code | JHI |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JJX |
| Subsequent Product Code | JLS |
| Subsequent Product Code | JLW |
| Subsequent Product Code | JZO |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-30 |
| Decision Date | 2004-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414599939 | K041133 | 000 |
| 00630414593302 | K041133 | 000 |
| 00630414573564 | K041133 | 000 |
| 00630414525464 | K041133 | 000 |
| 00630414519982 | K041133 | 000 |
| 00630414514413 | K041133 | 000 |
| 00630414503875 | K041133 | 000 |
| 00630414472898 | K041133 | 000 |
| 00630414225081 | K041133 | 000 |
| 00630414190860 | K041133 | 000 |
| 00630414187273 | K041133 | 000 |
| 00630414596914 | K041133 | 000 |
| 00630414599946 | K041133 | 000 |
| 00630414600505 | K041133 | 000 |
| 00630414599922 | K041133 | 000 |
| 00630414599915 | K041133 | 000 |
| 00630414585475 | K041133 | 000 |
| 00630414559704 | K041133 | 000 |
| 00630414554631 | K041133 | 000 |
| 00630414554624 | K041133 | 000 |
| 00630414554617 | K041133 | 000 |
| 00630414523286 | K041133 | 000 |
| 00630414125176 | K041133 | 000 |
| 00630414294247 | K041133 | 000 |
| 00630414600383 | K041133 | 000 |