← Product Code [IAB](/submissions/HE/subpart-b%E2%80%94biological-stains/IAB) · K844640

# POLYSTAT, BIOLOGICAL STAIN (K844640)

_Surgipath Medical Industries, Inc. · IAB · Jan 30, 1985 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-b%E2%80%94biological-stains/IAB/K844640

## Device Facts

- **Applicant:** Surgipath Medical Industries, Inc.
- **Product Code:** [IAB](/submissions/HE/subpart-b%E2%80%94biological-stains/IAB.md)
- **Decision Date:** Jan 30, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.1850
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

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**Source:** [https://fda.innolitics.com/submissions/PA/subpart-b%E2%80%94biological-stains/IAB/K844640](https://fda.innolitics.com/submissions/PA/subpart-b%E2%80%94biological-stains/IAB/K844640)

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