VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY
Device Facts
| Record ID | K926422 |
|---|---|
| Device Name | VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY |
| Applicant | Syva Co. |
| Product Code | GGJ · Hematology |
| Decision Date | Jun 2, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.8200 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.