The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Cell-dyn 1400 Multi-parameter Automated Hematology.
| Device ID | K903665 |
| 510k Number | K903665 |
| Device Name: | CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY |
| Classification | Counter, Differential Cell |
| Applicant | UNIPATH LTD. 850 MAUDE AVE. Mountain View, CA 94043 |
| Contact | Edmondson, Jr. |
| Correspondent | Edmondson, Jr. UNIPATH LTD. 850 MAUDE AVE. Mountain View, CA 94043 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-15 |
| Decision Date | 1990-10-04 |