ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER
Device Facts
| Record ID | K780946 |
|---|---|
| Device Name | ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER |
| Applicant | Hycel, Inc. |
| Product Code | JPJ · Hematology |
| Decision Date | Jul 27, 1978 |
| 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.
