SPOTTEST CALCOFLUOR WHITE REAGENT
Device Facts
| Record ID | K860795 |
|---|---|
| Device Name | SPOTTEST CALCOFLUOR WHITE REAGENT |
| Applicant | Difco Laboratories, Inc. |
| Product Code | LED · Hematology |
| Decision Date | Mar 12, 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.
