The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Advia 120 Hematology System, Cyanide-free High Determination.
| Device ID | K012904 |
| 510k Number | K012904 |
| Device Name: | ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION |
| Classification | Counter, Differential Cell |
| Applicant | BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-29 |
| Decision Date | 2001-09-21 |
| Summary: | summary |