WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S
Device Facts
| Record ID | K852138 |
|---|---|
| Device Name | WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S |
| Applicant | Canyon Diagnostics, Inc. |
| Product Code | IAF · Hematology |
| Decision Date | Jun 13, 1985 |
| 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.