The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Bayer Advia 2120 Hematology Analyzer With Autoslide System.
| Device ID | K042251 |
| 510k Number | K042251 |
| Device Name: | BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM |
| Classification | Counter, Differential Cell |
| Applicant | BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Andres Holle |
| Correspondent | Andres Holle BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-20 |
| Decision Date | 2004-09-17 |
| Summary: | summary |