KEY · Stainer, Tissue, Automated
Pathology · 21 CFR 864.3800 · Class 1
Overview
| Product Code | KEY |
|---|---|
| Device Name | Stainer, Tissue, Automated |
| Regulation | 21 CFR 864.3800 |
| Device Class | Class 1 |
| Review Panel | Pathology |
Identification
An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.
Classification Rationale
Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K771714 | SLIDE STAINERS GLS 360 & 360-1 | Honeywell, Inc. | Oct 5, 1977 | SESE |
Top Applicants
- Honeywell, Inc. — 1 clearance
