TISSUE GRAM STAIN
Device Facts
| Record ID | K864531 |
|---|---|
| Device Name | TISSUE GRAM STAIN |
| Applicant | Sigma Diagnostics, Inc. |
| Product Code | ICF · Hematology |
| Decision Date | Dec 22, 1986 |
| 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.
