HEMA-TEK II SLIDE STAINER
Device Facts
| Record ID | K771559 |
|---|---|
| Device Name | HEMA-TEK II SLIDE STAINER |
| Applicant | Miles Laboratories, Inc. |
| Product Code | KPA · Pathology |
| Decision Date | Aug 25, 1977 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.3800 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.