← Product Code [LCP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP) · K010748

# SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT (K010748)

_Beckman Coulter, Inc. · LCP · Jul 10, 2001 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K010748

## Device Facts

- **Applicant:** Beckman Coulter, Inc.
- **Product Code:** [LCP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP.md)
- **Decision Date:** Jul 10, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7470
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K010748](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K010748)

**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