Diadexus, Inc.: FDA clearances and approvals
Diadexus, Inc. has 7 FDA 510(k) clearances (first 2003, latest 2014), across 1 product code in 1 review panel. Median 510(k) review time: 105 days. openFDA lists 12 product recalls by a recalling firm named Diadexus, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 186 |
| 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 |
|---|---|---|---|
| NOE | Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2 | 7 | 7 |
Review panels
- Immunology (7)
Most recent Diadexus, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141575 | PLAC TEST FOR LP-PLA2 ACTIVITY | NOE | 2014-12-15 | 186 |
| K101853 | PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 | NOE | 2011-01-03 | 186 |
| K072599 | PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 | NOE | 2007-12-20 | 97 |
| K062234 | MODIFICATION TO DIADEXUS PLAC TEST | NOE | 2006-09-11 | 40 |
| K050523 | DIADEXUS PLAC TEST | NOE | 2005-06-15 | 105 |
| K040101 | MODIFICATION TO DIADEXUS PLAC TEST | NOE | 2004-02-05 | 16 |
| K030477 | DIADEXUS PLAC TEST | NOE | 2003-07-18 | 155 |
Recalls
12 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2010-08-20.
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 Diadexus, Inc. have?
Diadexus, Inc. has 7 FDA 510(k) clearances (first 2003, latest 2014), across 1 product code in 1 review panel.
How long does FDA take to clear Diadexus, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Diadexus, Inc.'s cleared 510(k)s is 105 days.
What devices does Diadexus, Inc. make?
Its most frequent FDA product codes are NOE (Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2, 7).
Has Diadexus, Inc. had device recalls?
openFDA lists 12 product recalls in 6 recall events by a recalling firm whose name matches Diadexus, Inc; the most recent began 2010-08-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Diadexus, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NOE, Diadexus, 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.