Editek, Inc.: FDA clearances and approvals
Editek, Inc. has 7 FDA 510(k) clearances (first 1994, latest 1996), across 5 product codes in 1 review panel. Median 510(k) review time: 73 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 |
|---|---|---|---|
| LCM | Enzyme Immunoassay, Phencyclidine | 3 | 3 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
Review panels
Most recent Editek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963692 | VERDICT PCP | LCM | 1996-12-10 | 85 |
| K963233 | EZ-SCREEN PROFILE | LCM | 1996-10-31 | 73 |
| K963529 | VERDICT BARBITURATES | DIS | 1996-10-30 | 56 |
| K963516 | VERDICT THC | LDJ | 1996-10-30 | 57 |
| K943712 | VERDICT OPIATES | DJG | 1994-11-17 | 108 |
| K943710 | VERDICT COCAINE | DIO | 1994-11-17 | 108 |
| K943711 | EZ-SCREEN:PCP | LCM | 1994-09-09 | 39 |
Recalls
openFDA lists no recalls under a recalling firm named Editek, Inc..
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 Editek, Inc. have?
Editek, Inc. has 7 FDA 510(k) clearances (first 1994, latest 1996), across 5 product codes in 1 review panel.
How long does FDA take to clear Editek, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Editek, Inc.'s cleared 510(k)s is 73 days.
What devices does Editek, Inc. make?
Its most frequent FDA product codes are LCM (Enzyme Immunoassay, Phencyclidine, 3); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 1); DIS (Enzyme Immunoassay, Barbiturate, 1).
Has Editek, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Editek, Inc. Related entities may recall under other names.
Next steps
- See all 7 Editek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LCM, Editek, Inc.'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.