← Product Code [JPD](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JPD) · K875102

# DETER. OF HEMOGLOBIN A2 USING THE DIAMAT (K875102)

_Bio-Rad · JPD · Feb 24, 1988 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JPD/K875102

## Device Facts

- **Applicant:** Bio-Rad
- **Product Code:** [JPD](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JPD.md)
- **Decision Date:** Feb 24, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7400
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A hemoglobin A2 assay is a device used to determine the hemoglobin A2 content of human blood. The measurement of hemoglobin A2 is used in the diagnosis of the thalassemias (hereditary hemolytic anemias characterized by decreased synthesis of one or more types of hemoglobin polypeptide chains).

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JPD/K875102](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JPD/K875102)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com