Browse hierarchy: [Pathology (PA)](/submissions/PA) → [Subpart D — Pathology Instrumentation and Accessories](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories) → [21 CFR 864.3400](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/864.3400) → KIM — Device For Sealing Microsections

# KIM · Device For Sealing Microsections

_Pathology · 21 CFR 864.3400 · Class 1_

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

## Overview

- **Product Code:** KIM
- **Device Name:** Device For Sealing Microsections
- **Regulation:** [21 CFR 864.3400](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/864.3400)
- **Device Class:** 1
- **Review Panel:** [Pathology](/submissions/PA)

## Identification

A device for sealing microsections is an automated instrument used to seal stained cells and microsections for histological and cytological examination.

## 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 |
| --- | --- | --- | --- | --- |
| [K780261](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KIM/K780261.md) | COVERSLIPPER | Shandon, Inc. | Apr 18, 1978 | 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/KIM](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KIM)

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