← Product Code [JBB](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBB) · K895745

# SICKLE CELL SOLUBILITY TEST KIT (K895745)

_Simmler, Inc. · JBB · Nov 29, 1989 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBB/K895745

## Device Facts

- **Applicant:** Simmler, Inc.
- **Product Code:** [JBB](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBB.md)
- **Decision Date:** Nov 29, 1989
- **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/JBB/K895745](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBB/K895745)

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