← Product Code [GHM](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM) · K842955

# SICKLE-HEME A/S HETEROZYGOUS CONTROL (K842955)

_Michclone Associates, Inc. · GHM · Aug 9, 1984 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K842955

## Device Facts

- **Applicant:** Michclone Associates, Inc.
- **Product Code:** [GHM](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM.md)
- **Decision Date:** Aug 9, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7825
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A sickle cell test is a device used to determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle cell diseases.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K842955](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K842955)

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