Browse hierarchy: [Pathology (PA)](/submissions/PA) → [Subpart D — Pathology Instrumentation and Accessories](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories) → [21 CFR 864.3010](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/864.3010) → KES — Coverslips, Microscope Slide

# KES · Coverslips, Microscope Slide

_Pathology · 21 CFR 864.3010 · Class 1_

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

## Overview

- **Product Code:** KES
- **Device Name:** Coverslips, Microscope Slide
- **Regulation:** [21 CFR 864.3010](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/864.3010)
- **Device Class:** 1
- **Review Panel:** [Pathology](/submissions/PA)
- **GMP exempt:** yes

## Identification

Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

## Classification Rationale

Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. The devices are also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K882881](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KES/K882881.md) | SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER | Sakura Finetek U.S.A., Inc. | Jul 28, 1988 | SESE |
| [K872874](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KES/K872874.md) | MICROSCOPE COVER GLASSES | Abco Dealers, Inc. | Aug 10, 1987 | SESE |
| [K771925](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KES/K771925.md) | KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP | Harleco | Nov 2, 1977 | SESE |

## Top Applicants

- Abco Dealers, Inc. — 1 clearance
- Harleco — 1 clearance
- Sakura Finetek U.S.A., Inc. — 1 clearance

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

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