IRIS URINE STAIN
Device Facts
| Record ID | K821503 |
|---|---|
| Device Name | IRIS URINE STAIN |
| Applicant | Intl. Remote Imaging Systems |
| Product Code | ICF · Hematology |
| Decision Date | Jun 3, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.1850 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
