← Product Code [HYI](/submissions/HE/subpart-b%E2%80%94biological-stains/HYI) · K821977

# GRAMSTAIN SET (K821977)

_Granite Diagnostics, Inc. · HYI · Jul 22, 1982 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-b%E2%80%94biological-stains/HYI/K821977

## Device Facts

- **Applicant:** Granite Diagnostics, Inc.
- **Product Code:** [HYI](/submissions/HE/subpart-b%E2%80%94biological-stains/HYI.md)
- **Decision Date:** Jul 22, 1982
- **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/HYI/K821977](https://fda.innolitics.com/submissions/PA/subpart-b%E2%80%94biological-stains/HYI/K821977)

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