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) → JBB — Solubility, Hemoglobin, Abnormal

# JBB · Solubility, Hemoglobin, Abnormal

_Hematology · 21 CFR 864.7825 · Class 2_

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

## Overview

- **Product Code:** JBB
- **Device Name:** Solubility, Hemoglobin, Abnormal
- **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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K932872](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBB/K932872.md) | SICKLE CELL TEST KIT | Histo-Med, Inc. | Aug 16, 1993 | SESE |
| [K895745](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBB/K895745.md) | SICKLE CELL SOLUBILITY TEST KIT | Simmler, Inc. | Nov 29, 1989 | SESE |

## Top Applicants

- Histo-Med, Inc. — 1 clearance
- Simmler, Inc. — 1 clearance

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

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