JPJ · Red-Cell Indices, Calculated
Hematology · 21 CFR 864.5300 · Class 2
Overview
| Product Code | JPJ |
|---|---|
| Device Name | Red-Cell Indices, Calculated |
| Regulation | 21 CFR 864.5300 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K904675 | QBC SYSTEM MCHC | Bd Becton Dickinson Vacutainer Systems Preanalytic | Nov 2, 1990 | SESE |
| K780946 | ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER | Hycel, Inc. | Jul 27, 1978 | SESE |
| K761304 | JTB 700 HEMATOLOGY ANALYZER | J.T. Baker Chemical Co. | Feb 1, 1977 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Hycel, Inc. — 1 clearance
- J.T. Baker Chemical Co. — 1 clearance
