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K Number
K953211
Device Name
AMYLASE (ETHYLIDENE PNGPG7) KIT
Manufacturer
RANDOX LABORATORIES, LTD.
Date Cleared
1996-06-21

(347 days)

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

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§ 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.