The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Advia Integrated Modular System (ims).
| Device ID | K992136 |
| 510k Number | K992136 |
| Device Name: | BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| 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 | CIT |
| Subsequent Product Code | CGX |
| Subsequent Product Code | DLZ |
| Subsequent Product Code | JLB |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-24 |
| Decision Date | 1999-11-09 |
| Summary: | summary |