The following data is part of a premarket notification filed by Toa Medical Electronics Usa, Inc. with the FDA for Sysmex Cc-180.
| Device ID | K830508 |
| 510k Number | K830508 |
| Device Name: | SYSMEX CC-180 |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | TOA MEDICAL ELECTRONICS USA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-17 |
| Decision Date | 1983-05-09 |