THROMBO SCREEN SICKLE CELL ASSAY SET
Device Facts
| Record ID | K854079 |
|---|---|
| Device Name | THROMBO SCREEN SICKLE CELL ASSAY SET |
| Applicant | Pacific Hemostasis |
| Product Code | GHM · Hematology |
| Decision Date | Oct 31, 1985 |
| 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.
