← Product Code [GHS](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHS) · K790943

# TRISEDTA-BORATE ELECTROPHORESIS FILM AGA (K790943)

_Corning Medical & Scientific · GHS · Jun 22, 1979 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHS/K790943

## Device Facts

- **Applicant:** Corning Medical & Scientific
- **Product Code:** [GHS](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHS.md)
- **Decision Date:** Jun 22, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7425
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A carboxyhemoglobin assay is a device used to determine the carboxyhemoglobin (the compound formed when hemoglobin is exposed to carbon monoxide) content of human blood as an aid in the diagnosis of carbon monoxide poisoning. This measurement may be made using methods such as spectroscopy, colorimetry, spectrophotometry, and gasometry.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHS/K790943](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHS/K790943)

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