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510(k) Data Aggregation
K Number
K062092Device Name
PREVU POINT OF CARE SKIN STEROL TEST
Manufacturer
Date Cleared
2006-09-15
(53 days)
Product Code
Regulation Number
862.1475Why did this record match?
Applicant Name (Manufacturer) :
PREMD, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Skin cholesterol as measured by PREVU* POC can be used as part of risk assessment for coronary heart disease in persons with a history of myocardial infarction and/or in persons suspected of having significant multi-vessel coronary artery disease (>50% stenosis in >1 vessel as diagnosed by coronary angiography) where further diagnostic evaluation is being considered. Test results, when considered in conjunction with clinical evaluation, blood cholesterol tests and other risk factors identified for coronary artery disease, will aid the physician in focusing diagnostic and patient management options.
Device Description
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