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Scimedx Corp.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K011348 PHASE II GBM IGG ANTIBODY EIA TESTMVJ2001-06-25 View
510(k) K011082 TPO IGG ANTIBODY EIA TESTJZO2001-06-06 View
510(k) K010625 EUROSPITAL EU-TTG IGA UMANAMVM2001-04-24 View
510(k) K010287 SCIMEDX PHASE II PR3 IGG ANTIBODY EIAMOB2001-03-16 View
510(k) K010289 SCIMEDX PHASE II MPO IGG ANTIBODY EIAMOB2001-03-07 View
510(k) K002189 GLIADIN IGG ANTIBODY EIA DETECTION SYSTEMMST2000-10-19 View
510(k) K002169 GLIADIN IGA ANTIBODY EIA DETECTION SYSTEMMST2000-10-19 View
510(k) K002107 IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.MVM2000-08-04 View
510(k) K994379 EU-TTG IGA ELISAMVM2000-02-18 View
510(k) K970198 IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIESDHN1997-02-20 View
510(k) K962360 IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIESMOB1996-09-30 View
510(k) K953495 EIA KIT FOR THE DETECTION OF GBM ANTIBODIESDBL1996-04-10 View
510(k) K954062 EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIESMOB1996-03-19 View
510(k) K954105 EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIESMOB1996-03-19 View
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