The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Advia Centaur Her-2/neu Assay.
| Device ID | K024017 |
| 510k Number | K024017 |
| Device Name: | BAYER ADVIA CENTAUR HER-2/NEU ASSAY |
| Classification | System, Test, Her-2/neu, Monitoring |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | NCW |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-04 |
| Decision Date | 2003-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414599182 | K024017 | 000 |
| 00630414599175 | K024017 | 000 |
| 00630414599168 | K024017 | 000 |
| 00630414599151 | K024017 | 000 |
| 00630414471235 | K024017 | 000 |
| 00630414471228 | K024017 | 000 |
| 00630414471211 | K024017 | 000 |
| 00630414469850 | K024017 | 000 |