The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Immuno 1 System, Upgraded For A Laboratory.
| Device ID | K983345 |
| 510k Number | K983345 |
| Device Name: | BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca Jr |
| Correspondent | Gabriel J Muraca Jr BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-23 |
| Decision Date | 1998-12-07 |
| Summary: | summary |