← Product Code [LIJ](/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/LIJ) · K855034

# AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT (K855034)

_Bartels Immunodiagnostic Supplies, Inc. · LIJ · Mar 11, 1986 · Pathology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/LIJ/K855034

## Device Facts

- **Applicant:** Bartels Immunodiagnostic Supplies, Inc.
- **Product Code:** [LIJ](/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/LIJ.md)
- **Decision Date:** Mar 11, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.4400
- **Device Class:** Class 1
- **Review Panel:** Pathology

## Regulatory 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).

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**Source:** [https://fda.innolitics.com/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/LIJ/K855034](https://fda.innolitics.com/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/LIJ/K855034)

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