ATS TB RAPID STAIN SET PRODUCT #034-45
Device Facts
| Record ID | K890148 |
|---|---|
| Device Name | ATS TB RAPID STAIN SET PRODUCT #034-45 |
| Applicant | Alpha-Tec Systems, Inc. |
| Product Code | ICL · Hematology |
| Decision Date | Jan 24, 1989 |
| 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.
