FDA 510(k) Applications Submitted by MELITA LAMBIRIS

FDA 510(k) Number Submission Date Device Name Applicant
K070064 01/05/2007 AMYLASE EPS REAGENT Thermo Fisher Scientific
K100060 01/11/2010 EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
K120202 01/23/2012 EON CHOLESTEROL REAGENT VITAL DIAGNOSTICS PTY. LTD
K110394 02/11/2011 ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
K120626 03/01/2012 EON CALCIUM REGENT VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
K111063 04/18/2011 VITAL SERUM CONTROLS VITAL DIAGNOSTICS (MANUFACTURING) PTY. LTD.
K052056 07/29/2005 DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM THERMO-ELECTRON CORP.
K112416 08/22/2011 CPK REAGENT VITAL DIAGNOSTICS (MANUFACTURING) PTYLTD
K062521 08/28/2006 OXALATE URINE CONTROLS (NORMAL AND ELEVATED) THERMO-ELECTRON CORP.


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