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) → KIO — Slide Stainer, Immersion Type

# KIO · Slide Stainer, Immersion Type

_Pathology · 21 CFR 864.3800 · Class 1_

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

## Overview

- **Product Code:** KIO
- **Device Name:** Slide Stainer, Immersion Type
- **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 |
| --- | --- | --- | --- | --- |
| [K890984](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KIO/K890984.md) | LINISTAIN SLS | Shandon, Inc. | Apr 4, 1989 | SESE |

## Top Applicants

- Shandon, Inc. — 1 clearance

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

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