Medical Device Manufacturer · US , Denvill , NJ

Scimedx Corp. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1996

Recent clearances: PHASE II GBM IGG ANTIBODY EIA TEST, TPO IGG ANTIBODY EIA TEST, EUROSPITAL EU-TTG IGA UMANA

View 14 510(k) Devices ↓

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Scimedx Corp. Immunology ✕

14 devices

1-12 of 14

Cleared Jun 25, 2001

PHASE II GBM IGG ANTIBODY EIA TEST

Immunology · 54d

Cleared Jun 06, 2001

TPO IGG ANTIBODY EIA TEST

Immunology · 57d

Cleared Apr 24, 2001

EUROSPITAL EU-TTG IGA UMANA

Immunology · 53d

Cleared Mar 16, 2001

SCIMEDX PHASE II PR3 IGG ANTIBODY EIA

Immunology · 44d

Cleared Mar 07, 2001

SCIMEDX PHASE II MPO IGG ANTIBODY EIA

Immunology · 35d

Cleared Oct 19, 2000

GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM

Immunology · 93d

Cleared Oct 19, 2000

GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM

Immunology · 92d

Cleared Aug 04, 2000

IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL...

Immunology · 23d

Cleared Feb 18, 2000

EU-TTG IGA ELISA

Immunology · 53d

Cleared Feb 20, 1997

IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES

Immunology · 30d

Cleared Sep 30, 1996

IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES

Immunology · 103d

Cleared Apr 10, 1996

EIA KIT FOR THE DETECTION OF GBM ANTIBODIES

Immunology · 259d