HEMOGLOBIN REAGENT
Device Facts
| Record ID | K831618 |
|---|---|
| Device Name | HEMOGLOBIN REAGENT |
| Applicant | Omega Medical Diagnostics |
| Product Code | GKR · Hematology |
| Decision Date | Jun 16, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5620 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.
