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K Number
K023549
Device Name
WIENER LAB AMILASA 405 AA LIQUIDA
Manufacturer
WIENER LABORATORIES S.A.I.C.
Date Cleared
2002-12-09

(48 days)

Product Code
JFJ
Regulation Number
862.1070
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 862.1070 Amylase test system.

(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.