FDA 510(k) Applications Submitted by MARK J KOPNITSKY

FDA 510(k) Number Submission Date Device Name Applicant
K970150 01/15/1997 MYCOPLASMA IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K991185 04/08/1999 BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM ZEUS SCIENTIFIC, INC.
K040111 01/20/2004 ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM ZEUS SCIENTIFIC, INC.
K990204 01/21/1999 GLIADIN IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K940362 01/26/1994 ANA SCREEN ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K000362 02/04/2000 MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K000363 02/04/2000 MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K941014 03/03/1994 ENA SCREEN ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K980821 03/03/1998 HELICOBACTER PYLORI IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K961012 03/13/1996 VZV IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K981014 03/18/1998 ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K981020 03/19/1998 ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K981021 03/19/1998 ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM ZEUS SCIENTIFIC, INC.
K000879 03/20/2000 THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE ZEUS SCIENTIFIC, INC.
K000880 03/20/2000 THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE ZEUS SCIENTIFIC, INC.
K941409 03/23/1994 ENA PROFILE-6 ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K961204 03/27/1996 MUMPS IGG TEST ZEUS SCIENTIFIC, INC.
K981120 03/27/1998 ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA ZEUS SCIENTIFIC, INC.
K961277 04/03/1996 RF IGM ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K021103 04/05/2002 MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K991179 04/07/1999 ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K991180 04/08/1999 BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM ZEUS SCIENTIFIC, INC.
K011244 04/23/2001 ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K971503 04/24/1997 MYCOPLASMA IGM ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K001393 05/03/2000 THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR ZEUS SCIENTIFIC, INC.
K991610 05/10/1999 ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. ZEUS SCIENTIFIC, INC.
K971784 05/14/1997 ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K991820 05/27/1999 HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI ZEUS SCIENTIFIC, INC.
K932742 06/08/1993 EBNA IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K992166 06/25/1999 THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR ZEUS SCIENTIFIC, INC.
K933267 07/06/1993 AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K042092 08/03/2004 ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM ZEUS SCIENTIFIC, INC.
K042118 08/06/2004 ATHENA MULTI-LYTE EBV IGG TEST SYSTEM ZEUS SCIENTIFIC, INC.
K973196 08/26/1997 ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS ZEUS SCIENTIFIC, INC.
K946373 09/07/1994 MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K042416 09/07/2004 ATHENA MULTI-LYTE ANA-II TEST SYSTEM ZEUS SCIENTIFIC, INC.
K944449 09/12/1994 EBV-VCA IGM ELISA TEST STSTEM ZEUS SCIENTIFIC, INC.
K983376 09/25/1998 THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S ZEUS SCIENTIFIC, INC.
K983378 09/25/1998 THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR. ZEUS SCIENTIFIC, INC.
K993250 09/28/1999 THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM. ZEUS SCIENTIFIC, INC.
K983418 09/29/1998 THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL ZEUS SCIENTIFIC, INC.
K983420 09/29/1998 THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO ZEUS SCIENTIFIC, INC.
K983422 09/29/1998 THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET ZEUS SCIENTIFIC, INC.
K983423 09/29/1998 THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE ZEUS SCIENTIFIC, INC.
K983425 09/29/1998 THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET ZEUS SCIENTIFIC, INC.
K983426 09/29/1998 THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC ZEUS SCIENTIFIC, INC.
K983464 10/01/1998 THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE ZEUS SCIENTIFIC, INC.
K983465 10/01/1998 THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE ZEUS SCIENTIFIC, INC.
K983656 10/19/1998 HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K983801 10/28/1998 THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO ZEUS SCIENTIFIC, INC.
K983803 10/28/1998 THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE ZEUS SCIENTIFIC, INC.
K983804 10/28/1998 THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR ZEUS SCIENTIFIC, INC.
K983805 10/28/1998 THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO ZEUS SCIENTIFIC, INC.
K964446 11/06/1996 MYELOPEROXIDASE ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K964448 11/06/1996 PROTEINASE-3 IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K964449 11/06/1996 ANCA SCREEN ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K984034 11/12/1998 THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR ZEUS SCIENTIFIC, INC.
K984120 11/18/1998 THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH ZEUS SCIENTIFIC, INC.
K984123 11/18/1998 THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E ZEUS SCIENTIFIC, INC.
K984126 11/18/1998 THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR ZEUS SCIENTIFIC, INC.
K984133 11/18/1998 THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH ZEUS SCIENTIFIC, INC.
K984135 11/18/1998 THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR ZEUS SCIENTIFIC, INC.
K984138 11/18/1998 APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K984139 11/18/1998 THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE ZEUS SCIENTIFIC, INC.
K984153 11/19/1998 THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. ZEUS SCIENTIFIC, INC.
K984170 11/20/1998 THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K984173 11/20/1998 THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K984175 11/20/1998 THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K984180 11/23/1998 THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K984181 11/23/1998 THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K984315 12/03/1998 THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE ZEUS SCIENTIFIC, INC.
K984317 12/03/1998 THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F ZEUS SCIENTIFIC, INC.
K984347 12/04/1998 THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F ZEUS SCIENTIFIC, INC.
K033802 12/08/2003 ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM ZEUS SCIENTIFIC, INC.
K984516 12/18/1998 THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET ZEUS SCIENTIFIC, INC.
K033977 12/23/2003 ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM ZEUS SCIENTIFIC, INC.
K990207 01/21/1999 GLIADIN IGA ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC.
K051484 06/06/2005 ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. ZEUS SCIENTIFIC, INC.


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