← Product Code [LCP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP) · K003120

# MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C (K003120)

_Roche Diagnostics Corp. · LCP · Dec 18, 2000 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K003120

## Device Facts

- **Applicant:** Roche Diagnostics Corp.
- **Product Code:** [LCP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP.md)
- **Decision Date:** Dec 18, 2000
- **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/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K003120](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K003120)

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