The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Advia 120 Hematology.
| Device ID | K003796 |
| 510k Number | K003796 |
| Device Name: | ADVIA 120 HEMATOLOGY |
| Classification | Counter, Differential Cell |
| 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 | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-08 |
| Decision Date | 2001-02-05 |