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) → KIN — Slide Stainer, Contact Type

# KIN · Slide Stainer, Contact Type

_Pathology · 21 CFR 864.3800 · Class 1_

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

## Overview

- **Product Code:** KIN
- **Device Name:** Slide Stainer, Contact 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 |
| --- | --- | --- | --- | --- |
| [K760032](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KIN/K760032.md) | TEST, MONO., DIFFERENTIAL SLIDE | Gamma Biologicals, Inc. | Aug 3, 1976 | SESE |

## Top Applicants

- Gamma Biologicals, Inc. — 1 clearance

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

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