← Product Code [JBD](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD) · K931503

# REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) (K931503)

_Helena Laboratories · JBD · Aug 16, 1993 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K931503

## Device Facts

- **Applicant:** Helena Laboratories
- **Product Code:** [JBD](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD.md)
- **Decision Date:** Aug 16, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7440
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K931503](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBD/K931503)

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