← Product Code [LGI](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGI) · K900702

# MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA (K900702)

_Innotron of Oregon, Inc. · LGI · Apr 12, 1990 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGI/K900702

## Device Facts

- **Applicant:** Innotron of Oregon, Inc.
- **Product Code:** [LGI](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGI.md)
- **Decision Date:** Apr 12, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3645
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGI/K900702](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGI/K900702)

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