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EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475

Page Type
Cleared 510(K)
510(k) Number
K100060
510(k) Type
Traditional
Applicant
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
12/15/2010
Days to Decision
338 days
Submission Type
Statement

EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475

Page Type
Cleared 510(K)
510(k) Number
K100060
510(k) Type
Traditional
Applicant
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
12/15/2010
Days to Decision
338 days
Submission Type
Statement