The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Immuno 1 Her-2/neu Assay.
| Device ID | K992228 |
| 510k Number | K992228 |
| Device Name: | BAYER IMMUNO 1 HER-2/NEU ASSAY |
| Classification | System, Test, Her-2/neu, Monitoring |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca |
| Correspondent | Gabriel J Muraca 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 | 1999-07-02 |
| Decision Date | 2000-09-29 |
| Summary: | summary |