Scimedx Corp.: FDA clearances and approvals
Scimedx Corp. has 14 FDA 510(k) clearances (first 1996, latest 2001), across 7 product codes in 1 review panel. Median 510(k) review time: 56 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 5 | 5 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 3 | 3 |
| MST | Antibodies, Gliadin | 2 | 2 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| JZO | System, Test, Thyroid Autoantibody | 1 | 1 |
| MVJ | Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | 1 | 1 |
Review panels
- Immunology (14)
Most recent Scimedx Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011348 | PHASE II GBM IGG ANTIBODY EIA TEST | MVJ | 2001-06-25 | 54 |
| K011082 | TPO IGG ANTIBODY EIA TEST | JZO | 2001-06-06 | 57 |
| K010625 | EUROSPITAL EU-TTG IGA UMANA | MVM | 2001-04-24 | 53 |
| K010287 | SCIMEDX PHASE II PR3 IGG ANTIBODY EIA | MOB | 2001-03-16 | 44 |
| K010289 | SCIMEDX PHASE II MPO IGG ANTIBODY EIA | MOB | 2001-03-07 | 35 |
| K002189 | GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM | MST | 2000-10-19 | 92 |
| K002169 | GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM | MST | 2000-10-19 | 93 |
| K002107 | IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. | MVM | 2000-08-04 | 23 |
| K994379 | EU-TTG IGA ELISA | MVM | 2000-02-18 | 53 |
| K970198 | IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES | DHN | 1997-02-20 | 30 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Scimedx Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Scimedx Corp. have?
Scimedx Corp. has 14 FDA 510(k) clearances (first 1996, latest 2001), across 7 product codes in 1 review panel.
How long does FDA take to clear Scimedx Corp.'s 510(k)s?
The median time from FDA receipt to decision across Scimedx Corp.'s cleared 510(k)s is 56 days.
What devices does Scimedx Corp. make?
Its most frequent FDA product codes are MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca), 5); MVM (Autoantibodies, Endomysial(Tissue Transglutaminase), 3); MST (Antibodies, Gliadin, 2).
Has Scimedx Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Scimedx Corp. Related entities may recall under other names.
Next steps
- See all 14 Scimedx Corp. clearances with predicates and recalls
- Run predicate analysis for product code MOB, Scimedx Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.