The following data is part of a premarket notification filed by Toa Medical Electronics Usa, Inc. with the FDA for Sysmex E-5000, Fully Automated Hematology Sys.
| Device ID | K850354 |
| 510k Number | K850354 |
| Device Name: | SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS |
| Classification | Counter, Differential Cell |
| Applicant | TOA MEDICAL ELECTRONICS USA, INC. 1515 E DEL AMO BLVD. Carson, CA 90746 |
| Contact | Richard Carstens |
| Correspondent | Richard Carstens TOA MEDICAL ELECTRONICS USA, INC. 1515 E DEL AMO BLVD. Carson, CA 90746 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-30 |
| Decision Date | 1985-05-20 |