HEMOTOLOGY CALIBRATOR
Device Facts
| Record ID | K813530 |
|---|---|
| Device Name | HEMOTOLOGY CALIBRATOR |
| Applicant | American Dade |
| Product Code | KSA · Hematology |
| Decision Date | Feb 22, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.8185 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A calibrator for red cell and white cell counting is a device that resembles red or white blood cells and that is used to set instruments intended to count red cells, white cells, or both. It is a suspension of particles or cells whose size, shape, concentration, and other 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.
