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510(k) Data Aggregation
K Number
K033155Device Name
BIOCENTREX CARDIAC PANEL
Manufacturer
BIOCENTREX
Date Cleared
2004-01-12
(104 days)
Product Code
MYT, DDR, JHX, MMI
Regulation Number
862.1215Why did this record match?
Applicant Name (Manufacturer) :
BIOCENTREX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For in vitro diagnostic use with the BioCentrex Analyzer to quantitatively measure cardiac troponin-I, creatine kinase MB and myoglobin concentrations in anti-coagulated whole blood, serum or plasma.
For in vitro diagnostic use with the BioCentrex Analyzer to measure cardiac troponin I, creatine kinase-MB, and myoglobin from whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with myocardial infarction.
Device Description
BioCentrex Cardiac Panel cartridges are used with the BioCentrex Analyzer to measure cardiac troponin I (CTnI), creatine kinase-MB, and myoglobin concentrations in whole blood, serum or plasma specimens.
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