← Product Code [DID](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DID) · K802038

# PHENYTOIN REAGENT TEST KIT (K802038)

_Beckman Instruments, Inc. · DID · Oct 23, 1980 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DID/K802038

## Device Facts

- **Applicant:** Beckman Instruments, Inc.
- **Product Code:** [DID](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DID.md)
- **Decision Date:** Oct 23, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3900
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DID/K802038](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DID/K802038)

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