← Product Code [JLC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLC) · K843382

# UROCYSTIN (K843382)

_Mission Pharmacal Co. · JLC · Jan 8, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLC/K843382

## Device Facts

- **Applicant:** Mission Pharmacal Co.
- **Product Code:** [JLC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLC.md)
- **Decision Date:** Jan 8, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1240
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A cystine test system is a device intended to measure the amino acid cystine in urine. Cystine measurements are used in the diagnosis of cystinuria (occurrence of cystine in urine). Patients with cystinuria frequently develop kidney calculi (stones).

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLC/K843382](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLC/K843382)

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