← Product Code [CEO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO) · K770456

# PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT (K770456)

_Icn Pharmaceuticals, Inc. · CEO · May 3, 1977 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO/K770456

## Device Facts

- **Applicant:** Icn Pharmaceuticals, Inc.
- **Product Code:** [CEO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO.md)
- **Decision Date:** May 3, 1977
- **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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO/K770456](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO/K770456)

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