← Product Code [KLT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT) · K850807

# COBAS FP REAGENTS FOR CARBAMAZEPINE (K850807)

_Roche Diagnostic Systems, Inc. · KLT · Mar 22, 1985 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K850807

## Device Facts

- **Applicant:** Roche Diagnostic Systems, Inc.
- **Product Code:** [KLT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT.md)
- **Decision Date:** Mar 22, 1985
- **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/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K850807](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K850807)

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