← Product Code [KQC](/submissions/HE/subpart-b%E2%80%94biological-stains/KQC) · K852843

# GENERAL DIAGNOSTICS COAG-A-MATE XC (K852843)

_Warner-Lambert Co. · KQC · Aug 13, 1985 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94biological-stains/KQC/K852843

## Device Facts

- **Applicant:** Warner-Lambert Co.
- **Product Code:** [KQC](/submissions/HE/subpart-b%E2%80%94biological-stains/KQC.md)
- **Decision Date:** Aug 13, 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/HE/subpart-b%E2%80%94biological-stains/KQC/K852843](https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94biological-stains/KQC/K852843)

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