← Product Code [LEF](/submissions/HE/subpart-b%E2%80%94biological-stains/LEF) · K871476

# SILVER STAIN REAGENT SYSTEM (K871476)

_Sigma Chemical Co. · LEF · May 21, 1987 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-b%E2%80%94biological-stains/LEF/K871476

## Device Facts

- **Applicant:** Sigma Chemical Co.
- **Product Code:** [LEF](/submissions/HE/subpart-b%E2%80%94biological-stains/LEF.md)
- **Decision Date:** May 21, 1987
- **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/LEF/K871476](https://fda.innolitics.com/submissions/PA/subpart-b%E2%80%94biological-stains/LEF/K871476)

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