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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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