← Product Code [JIR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR) · K970932

# ORGENTEC MICRO-ALBUMIN EIA ASSAY (K970932)

_American Laboratory Products Co., Ltd. · JIR · Apr 8, 1997 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR/K970932

## Device Facts

- **Applicant:** American Laboratory Products Co., Ltd.
- **Product Code:** [JIR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR.md)
- **Decision Date:** Apr 8, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1645
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR/K970932](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR/K970932)

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