Dako Corp.: FDA filings under this applicant name
FDA lists 54 510(k) clearances under the applicant name “Dako Corp.” (first 1981, latest 2002), across 25 product codes in 4 review panels. Median 510(k) review time under this name: 68 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | 14 | 14 |
| DEH | Lambda, Antigen, Antiserum, Control | 9 | 9 |
| DEW | Igg, Antigen, Antiserum, Control | 4 | 4 |
| CZW | Complement C3, Antigen, Antiserum, Control | 3 | 3 |
| CZP | Iga, Antigen, Antiserum, Control | 2 | 2 |
| DBI | Complement C4, Antigen, Antiserum, Control | 2 | 2 |
| DFH | Kappa, Antigen, Antiserum, Control | 2 | 2 |
| CZN | Iga, Fitc, Antigen, Antiserum, Control | 1 | 1 |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 1 | 1 |
| DAH | Gamma Globulin, Antigen, Antiserum, Control | 1 | 1 |
Plus 15 more product codes.
Review panels
- Immunology (35)
- Hematology (14)
- Pathology (3)
- Microbiology (2)
Most recent Dako Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020023 | DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING | MXZ | 2002-02-28 | 56 |
| K993957 | DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR | MYA | 2000-03-03 | 102 |
| K991454 | MOUSE IGG1 NEGATIVE CONTROLS | GKZ | 1999-06-21 | 56 |
| K991402 | DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1 | GKZ | 1999-06-21 | 60 |
| K980635 | DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 | GKZ | 1998-07-22 | 153 |
| K971905 | DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING | DEH | 1997-12-12 | 203 |
| K965022 | MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) | DEH | 1997-11-06 | 325 |
| K964974 | MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE | GKZ | 1997-06-24 | 194 |
| K961701 | MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE | GKZ | 1996-07-16 | 75 |
| K951965 | DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION | DEH | 1996-07-05 | 435 |
44 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dako Corp..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Dako Corp. (a text match, not an official crosswalk):
- J1460 — Injection, gamma globulin, intramuscular, 1 cc (via DAH)
- J1560 — Injection, gamma globulin, intramuscular, over 10 cc (via DAH)
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 Diagnostics , Ltd. (6 510(k)s)
- Dako North America, Inc. (4 510(k)s)
- Dako Denmark A/S (2 510(k)s)
- Dako A/S (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dako Corp.?
FDA lists 54 510(k) clearances under the applicant name “Dako Corp.” (first 1981, latest 2002), across 25 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dako Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dako Corp. is 68 days.
Which FDA product codes appear under Dako Corp.?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 14); DEH (Lambda, Antigen, Antiserum, Control, 9); DEW (Igg, Antigen, Antiserum, Control, 4).
Next steps
- See all 54 Dako Corp. clearances with predicates and recalls
- Run predicate analysis for product code GKZ, Dako Corp.'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.