Company ยท US
Scimedx Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2001. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 5 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 3 |
| MST | Antibodies, Gliadin | 2 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| JZO | System, Test, Thyroid Autoantibody | 1 |
| MVJ | Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 25, 2001 | K011348 | PHASE II GBM IGG ANTIBODY EIA TEST Scimedx Corp. | MVJ |
| Jun 6, 2001 | K011082 | TPO IGG ANTIBODY EIA TEST Scimedx Corp. | JZO |
| Apr 24, 2001 | K010625 | EUROSPITAL EU-TTG IGA UMANA Scimedx Corp. | MVM |
| Mar 16, 2001 | K010287 | SCIMEDX PHASE II PR3 IGG ANTIBODY EIA Scimedx Corp. | MOB |
| Mar 7, 2001 | K010289 | SCIMEDX PHASE II MPO IGG ANTIBODY EIA Scimedx Corp. | MOB |
| Oct 19, 2000 | K002189 | GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM Scimedx Corp. | MST |
| Oct 19, 2000 | K002169 | GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM Scimedx Corp. | MST |
| Aug 4, 2000 | K002107 | IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. Scimedx Corp. | MVM |
| Feb 18, 2000 | K994379 | EU-TTG IGA ELISA Scimedx Corp. | MVM |
| Feb 20, 1997 | K970198 | IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES Scimedx Corp. | DHN |
| Sep 30, 1996 | K962360 | IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES Scimedx Corp. | MOB |
| Apr 10, 1996 | K953495 | EIA KIT FOR THE DETECTION OF GBM ANTIBODIES Scimedx Corp. | DBL |
| Mar 19, 1996 | K954105 | EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES Scimedx Corp. | MOB |
| Mar 19, 1996 | K954062 | EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES Scimedx Corp. | MOB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||