The following data is part of a premarket notification filed by Toa Medical Electronics Usa, Inc. with the FDA for Sysmex Dd-100 Whole Blood Dilution System.
| Device ID | K882767 |
| 510k Number | K882767 |
| Device Name: | SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM |
| Classification | Apparatus, Automated Blood Cell Diluting |
| Applicant | TOA MEDICAL ELECTRONICS USA, INC. 4410 CERRITOS AVE. Los Alamitos, CA 90720 |
| Contact | Paul N Broden |
| Correspondent | Paul N Broden TOA MEDICAL ELECTRONICS USA, INC. 4410 CERRITOS AVE. Los Alamitos, CA 90720 |
| Product Code | GKH |
| CFR Regulation Number | 864.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-06 |
| Decision Date | 1988-07-18 |