The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Advia Ims System.
| Device ID | K993867 |
| 510k Number | K993867 |
| Device Name: | BAYER ADVIA IMS SYSTEM |
| Classification | Diazo Colorimetry, Bilirubin |
| 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 | CIG |
| Subsequent Product Code | JGJ |
| Subsequent Product Code | KLS |
| Subsequent Product Code | KNK |
| Subsequent Product Code | LCD |
| Subsequent Product Code | LCP |
| Subsequent Product Code | LDO |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-15 |
| Decision Date | 2000-04-10 |
| Summary: | summary |