CELL-DYN CALIBRATOR
Device Facts
| Record ID | K902892 |
|---|---|
| Device Name | CELL-DYN CALIBRATOR |
| Applicant | Unipath , Ltd. |
| Product Code | KRZ · Hematology |
| Decision Date | Sep 10, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.8165 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
