Medical Device Manufacturer · US , Denvill , NJ

Scimedx Corp.

14 submissions · 14 cleared · Since 1996
14
Total
14
Cleared
0
Denied

Scimedx Corp. — FDA 510(k) Submissions

Scimedx Corp. has submitted 14 FDA 510(k) premarket notifications since 1996, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Test System, Antineutrophil Cytoplasmic Antibodies (anca), Autoantibodies, Endomysial(tissue Transglutaminase), Antibodies, Gliadin, Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm), Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
PHASE II GBM IGG ANTIBODY EIA TEST
K011348 · MVJ Devices, Measure,... · Immunology
Jun 2001 54d
TPO IGG ANTIBODY EIA TEST
K011082 · JZO System, Test, Thyroid... · Immunology
Jun 2001 57d
EUROSPITAL EU-TTG IGA UMANA
K010625 · MVM Autoantibodies,... · Immunology
Apr 2001 53d
SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
K010287 · MOB Test System,... · Immunology
Mar 2001 44d
SCIMEDX PHASE II MPO IGG ANTIBODY EIA
K010289 · MOB Test System,... · Immunology
Mar 2001 35d
GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM
K002169 · MST Antibodies, Gliadin · Immunology
Oct 2000 93d
GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM
K002189 · MST Antibodies, Gliadin · Immunology
Oct 2000 92d
IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.
K002107 · MVM Autoantibodies,... · Immunology
Aug 2000 23d
EU-TTG IGA ELISA
K994379 · MVM Autoantibodies,... · Immunology
Feb 2000 53d
IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
K970198 · DHN Antinuclear Antibody,... · Immunology
Feb 1997 30d
IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES
K962360 · MOB Test System,... · Immunology
Sep 1996 103d
EIA KIT FOR THE DETECTION OF GBM ANTIBODIES
K953495 · DBL Multiple Autoantibodies,... · Immunology
Apr 1996 259d
EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES
K954062 · MOB Test System,... · Immunology
Mar 1996 203d
EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES
K954105 · MOB Test System,... · Immunology
Mar 1996 201d
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