The following data is part of a premarket notification filed by Toa Medical Electronics Usa, Inc. with the FDA for Sysmex Ne-1500, Modification.
| Device ID | K914744 |
| 510k Number | K914744 |
| Device Name: | SYSMEX NE-1500, MODIFICATION |
| Classification | Counter, Differential Cell |
| Applicant | TOA MEDICAL ELECTRONICS USA, INC. 4410 CERRITOS AVE. Los Alamitos, CA 90720 |
| Contact | Nina M Gamperling |
| Correspondent | Nina M Gamperling 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 | 1991-10-22 |
| Decision Date | 1991-12-30 |