Dako Diagnostics , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Dako Diagnostics , Ltd.” (first 1993, latest 1998), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 202 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 |
|---|---|---|---|
| GNW | Antisera, Cf, Influenza Virus A, B, C | 2 | 2 |
| GQP | Antisera, Neutralization, Parainfluenza Virus 1-4 | 1 | 1 |
| GQS | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | 1 | 1 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 1 | 1 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 | 1 |
Review panels
- Microbiology (6)
Most recent Dako Diagnostics , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981226 | IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 | GQP | 1998-09-28 | 188 |
| K973954 | IMAGEN RESPIRATORY SCREEN | GNW | 1997-12-22 | 74 |
| K962037 | IMAGEN RESPIRATORY SCREEN | GNW | 1996-12-26 | 216 |
| K940564 | IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION | LJC | 1996-01-11 | 707 |
| K943557 | IMAGEN | GQS | 1995-01-09 | 171 |
| K932384 | IDEIA(TM) ROTAVIRUS | LIQ | 1993-12-27 | 224 |
Recalls
openFDA lists no recalls under a recalling firm named Dako Diagnostics , Ltd..
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 Diagnostics , Ltd. (a text match, not an official crosswalk):
- G0008 — Administration of influenza virus vaccine (via GNW)
- Q2039 — Influenza virus vaccine, not otherwise specified (via GNW)
- Q2034 — Influenza virus vaccine, split virus, for intramuscular use (agriflu) (via GNW)
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 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 Diagnostics , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Dako Diagnostics , Ltd.” (first 1993, latest 1998), across 5 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 Diagnostics , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dako Diagnostics , Ltd. is 202 days.
Which FDA product codes appear under Dako Diagnostics , Ltd.?
The most frequent FDA product codes under this applicant name are GNW (Antisera, Cf, Influenza Virus A, B, C, 2); GQP (Antisera, Neutralization, Parainfluenza Virus 1-4, 1); GQS (Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4, 1).
Next steps
- See all 6 Dako Diagnostics , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GNW, Dako Diagnostics , Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.