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510(k) Data Aggregation
K Number
K120626Device Name
EON CALCIUM REGENT
Manufacturer
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
Date Cleared
2012-08-22
(174 days)
Product Code
CJY
Regulation Number
862.1145Why did this record match?
Applicant Name (Manufacturer) :
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vital Diagnostics Eon Calcium Reagent is a device intended to measure the total calcium level in serum and plasma using the Eon 100 Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Device Description
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K Number
K110394Device Name
ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
Manufacturer
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
Date Cleared
2011-06-09
(118 days)
Product Code
JIX
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATAC Serum Calibrator is intended for use with the ATAC Clinical Systems to establish points of reference that are used in the determination of albumin, calcium, cholesterol, creatinine, direct bilirubin, glucose, iron, magnesium, phosphorus, total bilirubin, total protein, triglycerides, urea and uric acid in human specimens.
Device Description
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K Number
K100060Device Name
EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475
Manufacturer
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
Date Cleared
2010-12-15
(338 days)
Product Code
KHS, CEK, CEM, CGZ, CIX, JFJ, JGS, JIT, JIX, JJE, KNK
Regulation Number
862.1160Why did this record match?
Applicant Name (Manufacturer) :
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Eon 100 is a discrete photometric chemistry analyzer for clinical use. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays. The Eon 100 has replaceable parts, automated maintenance monitoring and backup of both patient and system data.
The Eon 100 Chemistry Analyzer is intended to be used to assist the clinician with the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease.
The Eon 100 includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium and chloride in serum and plasma.
The Eon 100 is for in vitro diagnostic use only.
Device Description
The Eon 100 is a discrete photometric chemistry analyzer for clinical use. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays. The Eon 100 has replaceable parts, automated maintenance monitoring and backup of both patient and system data. The Eon 100 includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium and chloride in serum and plasma.
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