KQH · Red-Cell Indices
Hematology · 21 CFR 864.5300 · Class 2
Overview
| Product Code | KQH |
|---|---|
| Device Name | Red-Cell Indices |
| 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K862089 | V-MARC 88A COMPUTER | V.Marc, A Div. of Pictorial, Inc. | Jul 10, 1986 | SESE |
Top Applicants
- V.Marc, A Div. of Pictorial, Inc. — 1 clearance
