The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Reticulocyte Method.
| Device ID | K954607 |
| 510k Number | K954607 |
| Device Name: | RETICULOCYTE METHOD |
| Classification | Counter, Cell, Automated (particle Counter) |
| 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 | GKL |
| Subsequent Product Code | GKZ |
| Subsequent Product Code | JPJ |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-04 |
| Decision Date | 1996-08-30 |