Dako North America, Inc.: FDA clearances and approvals
Dako North America, Inc. has 4 FDA 510(k) clearances (first 2009, latest 2016), plus 2 PMA decisions, across 4 product codes in 1 review panel. Median 510(k) review time: 300 days. openFDA lists 8 product recalls by a recalling firm named Dako North America, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 300 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 29 |
| 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 |
|---|---|---|---|
| MXZ | Immunohistochemistry Assay, Antibody, Progesterone Receptor | 2 | 2 |
| MYA | Immunohistochemistry Antibody Assay, Estrogen Receptor | 2 | 2 |
| NKF | Immunohistochemistry Antibody Assay, C-Kit | 1 | 0 |
| PLS | Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 | 1 | 0 |
Review panels
- Pathology (6)
Most recent Dako North America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160922 | FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) | MXZ | 2016-05-03 | 29 |
| K130861 | MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) | MXZ | 2013-12-09 | 256 |
| K120663 | MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI | MYA | 2013-02-12 | 344 |
| K081286 | MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 | MYA | 2009-05-08 | 366 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P150027 | PMA | PD-L1 IHC 28-8 pharmDx | 2016-01-23 |
| P040011 | PMA | C-KIT PHARMDX | 2005-06-27 |
Recalls
8 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2018-02-02.
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 Dako North America, Inc. have?
Dako North America, Inc. has 4 FDA 510(k) clearances (first 2009, latest 2016), plus 2 PMA decisions, across 4 product codes in 1 review panel.
How long does FDA take to clear Dako North America, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Dako North America, Inc.'s cleared 510(k)s is 300 days.
What devices does Dako North America, Inc. make?
Its most frequent FDA product codes are MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor, 2); MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor, 2); NKF (Immunohistochemistry Antibody Assay, C-Kit, 1).
Has Dako North America, Inc. had device recalls?
openFDA lists 8 product recalls in 8 recall events by a recalling firm whose name matches Dako North America, Inc; the most recent began 2018-02-02. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 4 Dako North America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MXZ, Dako North America, 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.