← Product Code [CDF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF) · K843379

# VMA ASSAY KIT (K843379)

_Diagnostic Chemicals, Ltd. (Usa) · CDF · Sep 28, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF/K843379

## Device Facts

- **Applicant:** Diagnostic Chemicals, Ltd. (Usa)
- **Product Code:** [CDF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF.md)
- **Decision Date:** Sep 28, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1795
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A vanilmandelic acid test system is a device intended to measure vanilmandelic acid in urine. Measurements of vanilmandelic acid obtained by this device are used in the diagnosis and treatment of neuroblastoma, pheochromocytoma, and certain hypertensive conditions.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF/K843379](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDF/K843379)

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