The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Advia 60 Hematology System (in Vitro Diagnostic System).
| Device ID | K982802 |
| 510k Number | K982802 |
| Device Name: | BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) |
| Classification | Counter, Differential Cell |
| 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 | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-10 |
| Decision Date | 1998-09-22 |
| Summary: | summary |