← Product Code [JKL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKL) · K842310

# HEMATOLOGY ANALYZER (K842310)

_Hml Inc/Biotechnology Transfer · JKL · Sep 6, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94clinical-chemistry-test-systems/JKL/K842310

## Device Facts

- **Applicant:** Hml Inc/Biotechnology Transfer
- **Product Code:** [JKL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKL.md)
- **Decision Date:** Sep 6, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1060
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A delta-aminolevulinic acid test system is a device intended to measure the level of delta-aminolevulinic acid (a precursor of porphyrin) in urine. Delta-aminolevulinic acid measurements are used in the diagnosis and treatment of lead poisoning and certain porphyrias (diseases affecting the liver, gastrointestinal, and nervous systems that are accompanied by increased urinary excretion of various heme compounds including delta-aminolevulinic acid).

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94clinical-chemistry-test-systems/JKL/K842310](https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94clinical-chemistry-test-systems/JKL/K842310)

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