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510(k) Data Aggregation
K Number
K102700Device Name
LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS
Manufacturer
ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN
Date Cleared
2010-12-21
(92 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Lipid Controls: Assayed quality control materials for use with the Alere Cholestech LDX® system. Alere Cholestech LDX® Level 1 and Level 2 Controls are designed to be used only for monitoring the performance of test procedures on the Alere Cholestech LDX® System.
Multianalyte Control: Assayed quality control materials for use with the Alere Cholestech LDX® system. Alere Cholestech LDX® Level 1 and Level 2 Controls are designed to be used only for monitoring the performance of test procedures on the Alere Cholestech LDX® System.
Calibration Verification: Assayed calibration verification material is designed to be used for verifying the reportable range of tests on the Alere Cholestech LDX® System. This material is designed for use with any Alere Cholestech LDX® cassette type that includes total cholesterol, HDL cholesterol, triglycerides and glucose.
Device Description
Assayed Quality Control materials and Assayed Calibration Verification materials for use with the Alere Cholestech LDX® system.
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