JTB 700 HEMATOLOGY ANALYZER
Device Facts
| Record ID | K761304 |
|---|---|
| Device Name | JTB 700 HEMATOLOGY ANALYZER |
| Applicant | J.T. Baker Chemical Co. |
| Product Code | JPJ · Hematology |
| Decision Date | Feb 1, 1977 |
| 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.
