← Product Code [JNB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB) · K961515

# QUANTASE PHENYLALANINE ASSAY (K961515)

_Shield Diagnostics, Ltd. · JNB · Jun 12, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K961515

## Device Facts

- **Applicant:** Shield Diagnostics, Ltd.
- **Product Code:** [JNB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB.md)
- **Decision Date:** Jun 12, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1555
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K961515](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K961515)

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