SICKLE CELL SOLUBILITY TEST KIT
Device Facts
| Record ID | K895745 |
|---|---|
| Device Name | SICKLE CELL SOLUBILITY TEST KIT |
| Applicant | Simmler, Inc. |
| Product Code | JBB · Hematology |
| Decision Date | Nov 29, 1989 |
| 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.
