← Product Code [CGZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGZ) · K003664

# DELFIA NEONATAL IRT KIT, MODEL A005-110 (K003664)

_Wallac OY · CGZ · Feb 14, 2001 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGZ/K003664

## Device Facts

- **Applicant:** Wallac OY
- **Product Code:** [CGZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGZ.md)
- **Decision Date:** Feb 14, 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.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGZ/K003664](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGZ/K003664)

**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