Browse hierarchy: [Pathology (PA)](/submissions/PA) → [Subpart E — Specimen Preparation Reagents](/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents) → [21 CFR 864.4400](/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/864.4400) → LIJ — Peroxidase Anti-Peroxidase Immunohistochemical Stain

# LIJ · Peroxidase Anti-Peroxidase Immunohistochemical Stain

_Pathology · 21 CFR 864.4400 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/LIJ

## Overview

- **Product Code:** LIJ
- **Device Name:** Peroxidase Anti-Peroxidase Immunohistochemical Stain
- **Regulation:** [21 CFR 864.4400](/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/864.4400)
- **Device Class:** 1
- **Review Panel:** [Pathology](/submissions/PA)

## Identification

Enzyme preparations are products that are used in the histopathology laboratory for the following purposes:(1) To disaggregate tissues and cells already in established cultures for preparation into subsequent cultures (e.g., trypsin); (2) To disaggregate fluid specimens for cytological examination (e.g., papain for gastric lavage or trypsin for sputum liquefaction); (3) To aid in the selective staining of tissue specimens (e.g., diastase for glycogen determination).

## 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K855034](https://fda.innolitics.com/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/LIJ/K855034.md) | AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT | Bartels Immunodiagnostic Supplies, Inc. | Mar 11, 1986 | SESE |
| [K820336](https://fda.innolitics.com/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/LIJ/K820336.md) | DAKO PAP KIT K509 | Dako Corp. | Jul 13, 1982 | SESE |

## Top Applicants

- Bartels Immunodiagnostic Supplies, Inc. — 1 clearance
- Dako Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/LIJ](https://fda.innolitics.com/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/LIJ)

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