The following data is part of a premarket notification filed by Toa Medical Electronics Usa, Inc. with the FDA for Sysmex Ne-8000.
| Device ID | K883997 |
| 510k Number | K883997 |
| Device Name: | SYSMEX NE-8000 |
| Classification | Counter, Differential Cell |
| Applicant | TOA MEDICAL ELECTRONICS USA, INC. 4410 CERRITOS AVE. Los Alamitos, CA 90720 |
| Contact | Paul N Broden |
| Correspondent | Paul N Broden TOA MEDICAL ELECTRONICS USA, INC. 4410 CERRITOS AVE. Los Alamitos, CA 90720 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-20 |
| Decision Date | 1988-12-05 |