FDA 510(k) Applications Submitted by PENNY M LAYMAN

FDA 510(k) Number Submission Date Device Name Applicant
K053430 12/09/2005 TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER MEDTRONIC XOMED, INC.
K030679 03/04/2003 MAS LIPID LEVEL 1 AND 2 MEDICAL ANALYSIS SYSTEMS, INC.
K030942 03/26/2003 MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL MEDICAL ANALYSIS SYSTEMS, INC.
K040880 04/05/2004 MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 MEDICAL ANALYSIS SYSTEMS, INC.
K021155 04/10/2002 MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL MEDICAL ANALYSIS SYSTEMS, INC.
K031364 04/30/2003 MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 MEDICAL ANALYSIS SYSTEMS, INC.
K031392 05/02/2003 MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL MEDICAL ANALYSIS SYSTEMS, INC.
K031441 05/06/2003 URICHEMTRAK LIQUID ASSAYED URINE CONTROL MEDICAL ANALYSIS SYSTEMS, INC.
K031890 06/18/2003 MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL MEDICAL ANALYSIS SYSTEMS, INC.
K032335 07/29/2003 MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL MEDICAL ANALYSIS SYSTEMS, INC.
K032826 09/10/2003 MAS PAR TDM MEDICAL ANALYSIS SYSTEMS, INC.
K023307 10/03/2002 MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL MEDICAL ANALYSIS SYSTEMS, INC.
K023669 10/31/2002 MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA MEDICAL ANALYSIS SYSTEMS, INC.
K013734 11/13/2001 MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL MEDICAL ANALYSIS SYSTEMS, INC.
K023867 11/20/2002 MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3 MEDICAL ANALYSIS SYSTEMS, INC.
K023928 11/25/2002 MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL MEDICAL ANALYSIS SYSTEMS, INC.
K013995 12/04/2001 MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL MEDICAL ANALYSIS SYSTEMS, INC.


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