Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7825](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7825) → GHM — Test, Sickle Cell

# GHM · Test, Sickle Cell

_Hematology · 21 CFR 864.7825 · Class 2_

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

## Overview

- **Product Code:** GHM
- **Device Name:** Test, Sickle Cell
- **Regulation:** [21 CFR 864.7825](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7825)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (18 of 18)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K023656](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K023656.md) | SICKLE-CHEX SOLUBILITY KIT | Streck Laboratories, Inc. | Dec 30, 2002 | SESE |
| [K013316](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K013316.md) | SICKLE-CHEX | Streck Laboratories, Inc. | Nov 6, 2001 | SESE |
| [K960947](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K960947.md) | SAS SICKLE CELL TEST | Sa Scientific, Inc. | Jul 1, 1996 | SESE |
| [K911981](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K911981.md) | HEMOCARD HEMOGLOBIN S | Isolab, Inc. | Oct 9, 1991 | SESE |
| [K910430](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K910430.md) | HEMOCARD-AS | Isolab, Inc. | Apr 15, 1991 | SESE |
| [K872217](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K872217.md) | THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT | Pacific Hemostasis | Jul 31, 1987 | SESE |
| [K860812](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K860812.md) | SICKLE CELL REAGENT SET | Michclone Associates, Inc. | Apr 11, 1986 | SESE |
| [K860420](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K860420.md) | SICKLE CELL REAGENT SET | Sterling Diagnostics, Inc. | Feb 24, 1986 | SESE |
| [K854079](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K854079.md) | THROMBO SCREEN SICKLE CELL ASSAY SET | Pacific Hemostasis | Oct 31, 1985 | SESE |
| [K842152](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K842152.md) | SICKLING HEMOGLOBIN CONTROLS, NORMAL | Isolab, Inc. | Sep 9, 1984 | SESE |
| [K842955](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K842955.md) | SICKLE-HEME A/S HETEROZYGOUS CONTROL | Michclone Associates, Inc. | Aug 9, 1984 | SESE |
| [K842368](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K842368.md) | SICKLE CELL REAGENT SET | Livonia Diagnostics, Inc. | Jul 20, 1984 | SESE |
| [K841272](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K841272.md) | SICKLE-STAT HEMOGLOBIN S SCREEN KIT | Clinical Technology Corp. | Apr 13, 1984 | SESE |
| [K841170](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K841170.md) | SICKLE HB ASSAY | Isolab, Inc. | Apr 4, 1984 | SESE |
| [K831871](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K831871.md) | SICKLE-HEME A/S CONTROLS & A/A CONTROL | Anco Medical Reagents & Assoc. | Jul 28, 1983 | SESE |
| [K820642](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K820642.md) | SICKLE-CHECK | Panmed, Inc. | Apr 14, 1982 | SESE |
| [K811828](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K811828.md) | SICKLE CELL REAGENT SET | Anco Medical Reagents & Assoc. | Aug 12, 1981 | SESE |
| [K791971](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHM/K791971.md) | MONOJECT SICKLE CELL KIT | Sherwood Medical Co. | Nov 5, 1979 | SESE |

## Top Applicants

- Isolab, Inc. — 4 clearances
- Anco Medical Reagents & Assoc. — 2 clearances
- Michclone Associates, Inc. — 2 clearances
- Pacific Hemostasis — 2 clearances
- Streck Laboratories, Inc. — 2 clearances

---

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

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