← Product Code [JMX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMX) · K780847

# NINHYDRIN REAGENT KIT (K780847)

_Beckman Instruments, Inc. · JMX · Jun 13, 1978 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMX/K780847

## Device Facts

- **Applicant:** Beckman Instruments, Inc.
- **Product Code:** [JMX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMX.md)
- **Decision Date:** Jun 13, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1515
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A nitrogen (amino-nitrogen) test system is a device intended to measure amino acid nitrogen levels in serum, plasma, and urine. Nitrogen (amino-nitrogen) measurements are used in the diagnosis and treatment of certain forms of severe liver disease and renal disorders.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMX/K780847](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMX/K780847)

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