← Product Code [CGZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGZ) · K003668

# AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 (K003668)

_Wallac OY · CGZ · Feb 12, 2001 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGZ/K003668

## Device Facts

- **Applicant:** Wallac OY
- **Product Code:** [CGZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGZ.md)
- **Decision Date:** Feb 12, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1170
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGZ/K003668](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGZ/K003668)

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