← Product Code [LDP](/productcode/LDP) · K882719

# EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653 (K882719)

_Em Diagnostic Systems, Inc. · LDP · Aug 8, 1988 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K882719

## Device Facts

- **Applicant:** Em Diagnostic Systems, Inc.
- **Product Code:** [LDP](/productcode/LDP.md)
- **Decision Date:** Aug 8, 1988
- **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-staging.innolitics.com/device/K882719](https://fda-staging.innolitics.com/device/K882719)

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