← Product Code [JJB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJB) · K873553

# WAKO(TM) PRETEST 8A (K873553)

_Wako Chemicals USA, Inc. · JJB · Sep 22, 1987 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJB/K873553

## Device Facts

- **Applicant:** Wako Chemicals USA, Inc.
- **Product Code:** [JJB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJB.md)
- **Decision Date:** Sep 22, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1115
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJB/K873553](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJB/K873553)

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