IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2

• K Number: K003597
• Device Name: IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
• Manufacturer: DIAGNOSTIC PRODUCTS CORP.
• Date Cleared: 2001-02-05 ( 76 days)
• Product Code: LPS
• Regulation Number: 862.1377
• Type: Traditional
• Panel: Toxicology
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: K121533

Intended Use

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Device Description

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Summary

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Regulation Number and Section

§ 862.1377 Urinary homocystine (nonquantitative) test system.

(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.