Medical Device Manufacturer · US , Mchenry , IL

Zeus Scientific, Inc.

135 submissions · 135 cleared · Since 1976
135
Total
135
Cleared
0
Denied

Zeus Scientific, Inc. — FDA 510(k) Submissions

Zeus Scientific, Inc. has submitted 135 FDA 510(k) premarket notifications since 1976, of which 135 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Reagent, Borrelia Serological Reagent, System, Test, Anticardiolipin Immunological, Test System, Antineutrophil Cytoplasmic Antibodies (anca), Extractable Antinuclear Antibody, Antigen And Control, Antinuclear Antibody (enzyme-labeled), Antigen, Controls . Use the specialty filter in the sidebar to narrow results.

135 devices
1–25 of 135
Zeus IFA ANA HEp-2 Test System, Zeus dIFine
K201956 · DHN Antinuclear Antibody,... · Immunology
Apr 2022 654d
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System
K190907 · LSR Reagent, Borrelia... · Microbiology
Jul 2019 112d
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System
K191240 · LSR Reagent, Borrelia... · Microbiology
Jul 2019 82d
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System
K191398 · LSR Reagent, Borrelia... · Microbiology
Jul 2019 66d
ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
K113397 · LSR Reagent, Borrelia... · Microbiology
Jul 2012 252d
ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
K102425 · MID System, Test,... · Immunology
Dec 2011 474d
ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
K103603 · MYF Enzyme Linked... · Microbiology
May 2011 163d
ZEUS ELISA HSV GC-I IGG TEST SYSTEM
K103363 · MXJ Enzyme Linked... · Microbiology
Apr 2011 160d
ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM
K102283 · LIP Enzyme Linked... · Microbiology
Feb 2011 182d
ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM
K093784 · OPM Multiplex Immunoassay For... · Microbiology
Jul 2010 219d
ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM
K100728 · LSR Reagent, Borrelia... · Microbiology
Jul 2010 113d
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM
K072178 · MXJ Enzyme Linked... · Microbiology
May 2008 298d
ATHENA MULTI-LYTE GBM TEST SYSTEM
K071219 · MVJ Devices, Measure,... · Immunology
Dec 2007 218d
ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM
K070317 · LFY Enzyme Linked... · Microbiology
Jul 2007 153d
ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM
K063186 · LFX Enzyme Linked... · Microbiology
Mar 2007 152d
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.
K051484 · LFY Enzyme Linked... · Microbiology
Dec 2005 182d
ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
K042118 · JRY Antiserum, Fluorescent,... · Microbiology
Apr 2005 266d
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
K042092 · LJN Antibody Igm, If,... · Microbiology
Apr 2005 252d
ATHENA MULTI-LYTE ANA-II TEST SYSTEM
K042416 · LKJ Antinuclear Antibody,... · Immunology
Oct 2004 31d
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
K040111 · MOB Test System,... · Immunology
Apr 2004 76d
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
K033977 · JZO System, Test, Thyroid... · Immunology
Mar 2004 90d
ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
K033802 · DHR System, Test, Rheumatoid... · Immunology
Feb 2004 81d
MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
K021103 · LKJ Antinuclear Antibody,... · Immunology
Apr 2002 19d
ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM
K011244 · LKJ Antinuclear Antibody,... · Immunology
Dec 2001 231d
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
K001393 · MST Antibodies, Gliadin · Immunology
Jun 2000 35d

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