← Product Code [JIR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR) · K894169

# BIOTEL MICROALBUMINURIA (TM) (K894169)

_American Diagnostic Corp. · JIR · Sep 18, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR/K894169

## Device Facts

- **Applicant:** American Diagnostic Corp.
- **Product Code:** [JIR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR.md)
- **Decision Date:** Sep 18, 1989
- **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/K894169](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR/K894169)

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