← Product Code [JNB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB) · K891070

# PHENYLALANINE (NINHYDRIN REACTION) (K891070)

_Alpkem Corp. · JNB · Oct 27, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K891070

## Device Facts

- **Applicant:** Alpkem Corp.
- **Product Code:** [JNB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB.md)
- **Decision Date:** Oct 27, 1989
- **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/K891070](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K891070)

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