ACCESS FOLATE ASSAY (MODIFICATION)

• K Number: K955434
• Device Name: ACCESS FOLATE ASSAY (MODIFICATION)
• Manufacturer: BECKMAN COULTER, INC.
• Date Cleared: 1996-01-29 ( 119 days)
• Product Code: CGN
• Regulation Number: 862.1295
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: K060774

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

§ 862.1295 Folic acid test system.

(a)
Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.(b)
Classification. Class II.