← Product Code [LDP](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP) · K952949

# ACETAMINOPHEN ASSAY (K952949)

_Diagnostic Chemicals , Ltd. · LDP · Sep 6, 1995 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K952949

## Device Facts

- **Applicant:** Diagnostic Chemicals , Ltd.
- **Product Code:** [LDP](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP.md)
- **Decision Date:** Sep 6, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3030
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K952949](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDP/K952949)

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