The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Additional Ims Assays For The Bayer Advia Ims System.
| Device ID | K992399 |
| 510k Number | K992399 |
| Device Name: | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muracaa Jr |
| Correspondent | Gabriel J Muracaa Jr BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | CIX |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CHH |
| Subsequent Product Code | CHS |
| Subsequent Product Code | CIG |
| Subsequent Product Code | JGS |
| Subsequent Product Code | KXT |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-19 |
| Decision Date | 1999-09-15 |
| Summary: | summary |