← [Clinical Chemistry](/submissions/CH) · Product Code MZU # MZU · System, Test, Sodium, Enzymatic Method _Clinical Chemistry · 21 CFR 862.1665 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MZU ## Overview - **Product Code:** MZU - **Device Name:** System, Test, Sodium, Enzymatic Method - **Regulation:** 21 CFR 862.1665 - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) - **3rd-party reviewable:** yes ## Identification A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. ## Classification Rationale Class II. ## Cleared Devices (2) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K082763](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MZU/K082763.md) | DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B | Diazyme Laboratories | Nov 12, 2008 | SESE | | [K042189](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MZU/K042189.md) | DIAZYME SODIUM ENZYMATIC ASSAY | Diazyme Laboratories | Oct 7, 2004 | SESE | ## Top Applicants - Diazyme Laboratories — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MZU](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MZU) **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 as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MZU