← Product Code [LCP](/productcode/LCP) · K803186

# NORMAL AND ELEVATED CONTROL FOR GLYCO. (K803186)

_Applied Clinical Research Laboratories · LCP · Jan 21, 1981 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K803186

## Device Facts

- **Applicant:** Applied Clinical Research Laboratories
- **Product Code:** [LCP](/productcode/LCP.md)
- **Decision Date:** Jan 21, 1981
- **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.

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**Source:** [https://fda.innolitics.com/device/K803186](https://fda.innolitics.com/device/K803186)

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