The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Cell-dyn Calibrator.
| Device ID | K902892 |
| 510k Number | K902892 |
| Device Name: | CELL-DYN CALIBRATOR |
| Classification | Calibrator For Hemoglobin And Hematocrit Measurement |
| Applicant | UNIPATH LTD. 850 MAUDE AVE. Mountain View, CA 94043 |
| Contact | Andrea Herrmann |
| Correspondent | Andrea Herrmann UNIPATH LTD. 850 MAUDE AVE. Mountain View, CA 94043 |
| Product Code | KRZ |
| CFR Regulation Number | 864.8165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-02 |
| Decision Date | 1990-09-10 |