The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Advia Ims System; C-reactive Protein System.
| Device ID | K012337 |
| 510k Number | K012337 |
| Device Name: | BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM |
| Classification | System, Test, C-reactive Protein |
| 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 | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-24 |
| Decision Date | 2001-12-06 |
| Summary: | summary |