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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) Ptyltd
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) Ptyltd
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
12/15/2010
Days to Decision
338 days
Submission Type
Statement