SICKLE CELL REAGENT SET
Device Facts
| Record ID | K842368 |
|---|---|
| Device Name | SICKLE CELL REAGENT SET |
| Applicant | Livonia Diagnostics, Inc. |
| Product Code | GHM · Hematology |
| Decision Date | Jul 20, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7825 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A sickle cell test is a device used to determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle cell diseases.
