K Number
K011145Device Name
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
Manufacturer
Date Cleared
2001-06-25
(91 days)
Product Code
Regulation Number
862.1070AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
More Information
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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.
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