The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Advia Ims System; 200 + 3.
| Device ID | K000921 |
| 510k Number | K000921 |
| Device Name: | BAYER ADVIA IMS SYSTEM; 200 + 3 |
| Classification | Alpha-1-lipoprotein, Antigen, Antiserum, Control |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Fredrick Clerie |
| Correspondent | Fredrick Clerie BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | DER |
| Subsequent Product Code | CFR |
| Subsequent Product Code | DFC |
| CFR Regulation Number | 866.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-22 |
| Decision Date | 2000-05-18 |