QBC SYSTEM MCHC
Device Facts
| Record ID | K904675 |
|---|---|
| Device Name | QBC SYSTEM MCHC |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Product Code | JPJ · Hematology |
| Decision Date | Nov 2, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A red cell indices device, usually part of a larger system, calculates or directly measures the erythrocyte mean corpuscular volume (MCV), the mean corpuscular hemoglobin (MCH), and the mean corpuscular hemoglobin concentration (MCHC). The red cell indices are used for the differential diagnosis of anemias.
