← Product Code [CEO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO) · K852003

# IP ACID REAGENT IP MOLY BDATE REAGENT (K852003)

_Alpkem Corp. · CEO · May 31, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO/K852003

## Device Facts

- **Applicant:** Alpkem Corp.
- **Product Code:** [CEO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO.md)
- **Decision Date:** May 31, 1985
- **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/K852003](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEO/K852003)

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