The following data is part of a premarket notification filed by Toa Medical Electronics Usa, Inc. with the FDA for Sysmex R-1000 Automated Reticulocyte Analyzer.
| Device ID | K894539 |
| 510k Number | K894539 |
| Device Name: | SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | TOA MEDICAL ELECTRONICS USA, INC. 4410 CERRITOS AVE. Los Alamitos, CA 90720 |
| Contact | Robert W Pearson |
| Correspondent | Robert W Pearson TOA MEDICAL ELECTRONICS USA, INC. 4410 CERRITOS AVE. Los Alamitos, CA 90720 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-09-26 |