3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE
Device Facts
| Record ID | K912357 |
|---|---|
| Device Name | 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE |
| Applicant | R&D Systems, Inc. |
| Product Code | KRX · Hematology |
| Decision Date | Jul 9, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.8150 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. 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.
