Scimedx Corp.
Denvill, NJ, US
Scimedx Corp. appears in FDA device records in Denvill, NJ. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Scimedx Corp. between 1996 and 2001. The busiest year on record is 2001, with 5. The most recent is 2001, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 4 |
| 1997 | 1 |
| 2000 | 4 |
| 2001 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K011348 | PHASE II GBM IGG ANTIBODY EIA TEST | MVJ | Substantially Equivalent | |
| K011082 | TPO IGG ANTIBODY EIA TEST | JZO | Substantially Equivalent | |
| K010625 | EUROSPITAL EU-TTG IGA UMANA | MVM | Substantially Equivalent | |
| K010287 | SCIMEDX PHASE II PR3 IGG ANTIBODY EIA | MOB | Substantially Equivalent | |
| K010289 | SCIMEDX PHASE II MPO IGG ANTIBODY EIA | MOB | Substantially Equivalent | |
| K002189 | GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM | MST | Substantially Equivalent | |
| K002169 | GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM | MST | Substantially Equivalent | |
| K002107 | IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. | MVM | Substantially Equivalent | |
| K994379 | EU-TTG IGA ELISA | MVM | Substantially Equivalent | |
| K970198 | IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES | DHN | Substantially Equivalent | |
| K962360 | IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES | MOB | Substantially Equivalent | |
| K953495 | EIA KIT FOR THE DETECTION OF GBM ANTIBODIES | DBL | Substantially Equivalent | |
| K954105 | EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES | MOB | Substantially Equivalent | |
| K954062 | EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES | MOB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MSTAntibodies, Gliadin
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- MVMAutoantibodies, Endomysial(Tissue Transglutaminase)
- MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
- DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- JZOSystem, Test, Thyroid Autoantibody
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain