← Product Code [CEO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO) · K971363

# SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT (K971363)

_Carolina Liquid Chemistries Corp. · CEO · Apr 21, 1997 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO/K971363

## Device Facts

- **Applicant:** Carolina Liquid Chemistries Corp.
- **Product Code:** [CEO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO.md)
- **Decision Date:** Apr 21, 1997
- **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/K971363](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO/K971363)

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