The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Advia Ims System.
| Device ID | K010201 |
| 510k Number | K010201 |
| Device Name: | BAYER ADVIA IMS SYSTEM |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Fredick Clerie |
| Correspondent | Fredick Clerie BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-22 |
| Decision Date | 2001-03-29 |