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K Number
K000494

Validate with FDA (Live)

Device Name
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
Manufacturer
BECKMAN COULTER, INC.
Date Cleared
2000-04-14

(59 days)

Product Code
LDP
Regulation Number
862.3030
Type
Traditional
Panel
Toxicology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
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§ 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.