Home / Companies / Scimedx Corp.

Scimedx Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K011348PHASE II GBM IGG ANTIBODY EIA TESTJune 25, 2001
K011082TPO IGG ANTIBODY EIA TESTJune 6, 2001
K010625EUROSPITAL EU-TTG IGA UMANAApril 24, 2001
K010287SCIMEDX PHASE II PR3 IGG ANTIBODY EIAMarch 16, 2001
K010289SCIMEDX PHASE II MPO IGG ANTIBODY EIAMarch 7, 2001
K002169GLIADIN IGA ANTIBODY EIA DETECTION SYSTEMOctober 19, 2000
K002189GLIADIN IGG ANTIBODY EIA DETECTION SYSTEMOctober 19, 2000
K002107IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGAAugust 4, 2000
K994379EU-TTG IGA ELISAFebruary 18, 2000
K970198IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIESFebruary 20, 1997
K962360IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIESSeptember 30, 1996
K953495EIA KIT FOR THE DETECTION OF GBM ANTIBODIESApril 10, 1996
K954062EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIESMarch 19, 1996
K954105EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIESMarch 19, 1996