Dako Denmark A/S: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Dako Denmark A/S” (first 2017, latest 2017), plus 2 PMA decisions, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 352 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 2 | 352 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dako Denmark A/S took a median 352 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 65 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MXZ | Immunohistochemistry Assay, Antibody, Progesterone Receptor | 1 | 1 |
| MYA | Immunohistochemistry Antibody Assay, Estrogen Receptor | 1 | 1 |
| NXG | Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion | 1 | 0 |
| NYQ | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer | 1 | 0 |
Review panels
- Pathology (4)
Most recent Dako Denmark A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) | MYA | 2017-12-21 | 352 |
| K170005 | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) | MXZ | 2017-12-21 | 352 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P100024 | PMA | HER2 CISH PHARMDX KIT | 2011-11-30 |
| P050045 | PMA | DAKO TOP2A FISH PHARMDX KIT | 2008-01-11 |
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2019-11-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Dako Corp. (54 510(k)s)
- Dako Diagnostics , Ltd. (6 510(k)s)
- Dako North America, Inc. (4 510(k)s)
- Dako A/S (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dako Denmark A/S?
FDA lists 2 510(k) clearances under the applicant name “Dako Denmark A/S” (first 2017, latest 2017), plus 2 PMA decisions, across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dako Denmark A/S?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dako Denmark A/S is 352 days.
Which FDA product codes appear under Dako Denmark A/S?
The most frequent FDA product codes under this applicant name are MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor, 1); MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor, 1); NXG (Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion, 1).
Next steps
- See all 2 Dako Denmark A/S clearances with predicates and recalls
- Run predicate analysis for product code MXZ, Dako Denmark A/S's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.