← Product Code [GHM](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM) · K831871

# SICKLE-HEME A/S CONTROLS & A/A CONTROL (K831871)

_Anco Medical Reagents & Assoc. · GHM · Jul 28, 1983 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K831871

## Device Facts

- **Applicant:** Anco Medical Reagents & Assoc.
- **Product Code:** [GHM](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM.md)
- **Decision Date:** Jul 28, 1983
- **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/CH/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K831871](https://fda.innolitics.com/submissions/CH/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K831871)

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