LIPASE REAGENT SET (COLIPASE METHOD)

• K Number: K970124
• Device Name: LIPASE REAGENT SET (COLIPASE METHOD)
• Manufacturer: TECO DIAGNOSTICS
• Date Cleared: 1997-03-06 ( 51 days)
• Product Code: CET
• Regulation Number: 862.1465
• Type: Traditional
• Panel: Clinical Chemistry
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 862.1465 Lipase test system.

(a)
Identification. A lipase test system is a device intended to measure the activity of the enzymes lipase in serum. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.