← Product Code [JMT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT) · K875248

# BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS (K875248)

_Bioscan Instruments, Inc. · JMT · Feb 24, 1988 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT/K875248

## Device Facts

- **Applicant:** Bioscan Instruments, Inc.
- **Product Code:** [JMT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT.md)
- **Decision Date:** Feb 24, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1510
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT/K875248](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMT/K875248)

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