FDA 510(k) Applications Submitted by EWA NADOLCZAK

FDA 510(k) Number Submission Date Device Name Applicant
K070317 02/02/2007 ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K100728 03/15/2010 ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM ZEUS SCIENTIFIC, INC.
K071219 05/02/2007 ATHENA MULTI-LYTE GBM TEST SYSTEM ZEUS SCIENTIFIC, INC.
K072178 08/06/2007 ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM ZEUS SCIENTIFIC, INC.
K102283 08/12/2010 ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM ZEUS SCIENTIFIC, INC.
K102425 08/25/2010 ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K063186 10/20/2006 ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM ZEUS SCIENTIFIC, INC.
K103363 11/17/2010 ZEUS ELISA HSV GC-I IGG TEST SYSTEM ZEUS SCIENTIFIC, INC.
K113397 11/17/2011 ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM ZEUS SCIENTIFIC, INC.
K103603 12/08/2010 ZEUS ELISA HSV GG-2 IGG TEST SYSTEM ZEUS SCIENTIFIC, INC.
K093784 12/09/2009 ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM ZEUS SCIENTIFIC, INC.
K093837 12/15/2009 ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM ZEUS SCIENTIFIC, INC. (ZEUS)


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