← Product Code [CEO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO) · K863264

# INORGANIC PHOSPHORUS PROCEDURE (K863264)

_Data Medical Associates, Inc. · CEO · Sep 11, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO/K863264

## Device Facts

- **Applicant:** Data Medical Associates, Inc.
- **Product Code:** [CEO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO.md)
- **Decision Date:** Sep 11, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1580
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO/K863264](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO/K863264)

**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