The following data is part of a premarket notification filed by Toa Medical Electronics Usa, Inc. with the FDA for Sysmex Pda-410 (particle Distrib. Analy.
| Device ID | K822758 |
| 510k Number | K822758 |
| Device Name: | SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | TOA MEDICAL ELECTRONICS USA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-14 |
| Decision Date | 1982-10-18 |