EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL by DADE BEHRING, INC. | FDA 510(k) Summary

FDA 510(k) Search

K Number

Validate with FDA (Live)

Device Name

EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL

Manufacturer

DADE BEHRING, INC.

Date Cleared

2000-10-11

(55 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

Intended Use

Device Description

AI/ML Overview

Summary

Loading...

Regulation Number and Section

§ 862.3030 Acetaminophen test system.

(a)
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.(b)
Classification. Class II.