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K Number
K022772
Device Name
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
Manufacturer
HEMAGEN DIAGNOSTICS, INC.
Date Cleared
2002-09-17

(27 days)

Product Code
MRR
Regulation Number
862.1475
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This reagent is intended for the quantitative measurement of LDL Cholesterol (LDL-C) levels in serum or plasma samples. LDL-Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.

Device Description

RAICHEM® LDL – Cholesterol Direct Reagent

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "RAICHEM® LDL - Cholesterol Direct Reagent." It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information from the provided text.

§ 862.1475 Lipoprotein test system.

(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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.