Browse hierarchy: [Pathology (PA)](/submissions/PA) → [Subpart D — Pathology Instrumentation and Accessories](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories) → [21 CFR 864.3800](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/864.3800) → KEY — Stainer, Tissue, Automated

# KEY · Stainer, Tissue, Automated

_Pathology · 21 CFR 864.3800 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KEY

## Overview

- **Product Code:** KEY
- **Device Name:** Stainer, Tissue, Automated
- **Regulation:** [21 CFR 864.3800](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/864.3800)
- **Device Class:** 1
- **Review Panel:** [Pathology](/submissions/PA)

## 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](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KEY/K771714.md) | SLIDE STAINERS GLS 360 & 360-1 | Honeywell, Inc. | Oct 5, 1977 | SESE |

## Top Applicants

- Honeywell, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KEY](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KEY)

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