Abbott Ireland Diagnostics Division: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Abbott Ireland Diagnostics Division” (first 2021, latest 2023), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 424 days. Since 2017 the median was 424 days, against 242 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Abbott, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 384 |
| 2022 | 6 | 460 |
| 2023 | 1 | 266 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Abbott Ireland Diagnostics Division took a median 424 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 242 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CJW | Bromcresol Purple Dye-Binding, Albumin | 1 | 1 |
| JFJ | Catalytic Methods, Amylase | 1 | 1 |
Review panels
Most recent Abbott Ireland Diagnostics Division 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223317 | Alkaline Phosphatase2 | CJE | 2023-07-21 | 266 |
| K223324 | Total Bilirubin2 | CIG | 2022-12-29 | 59 |
| K203597 | Cholesterol2 | CHH | 2022-06-30 | 568 |
| K203771 | Urea Nitrogen2 | CDQ | 2022-05-31 | 524 |
| K210633 | Amylase2 | JFJ | 2022-05-26 | 449 |
| K210452 | Creatinine2 | CGX | 2022-03-22 | 399 |
| K203530 | Albumin BCP2 | CJW | 2022-03-18 | 471 |
| K203248 | Albumin BCG2 | CIX | 2021-11-23 | 384 |
Recalls
12 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2019-02-05.
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.
- Abbott Laboratories (889 510(k)s)
- ABBOTT MEDICAL (60 510(k)s)
- Abbott Vascular (50 510(k)s)
- Abbott Diabetes Care, Inc. (39 510(k)s)
- Abbott Diagnostics (28 510(k)s)
- Abbott Point of Care, Inc. (22 510(k)s)
- Abbott Molecular, Inc. (18 510(k)s)
- Abbott Mfg., Inc. (14 510(k)s)
- Abbott Medical Optics, Inc. (13 510(k)s)
- Abbott (13 510(k)s)
- Abbott Spine, Inc. (13 510(k)s)
- Abbott Diagnostics Scarborough, Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Abbott Ireland Diagnostics Division?
FDA lists 8 510(k) clearances under the applicant name “Abbott Ireland Diagnostics Division” (first 2021, latest 2023), across 8 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 Abbott Ireland Diagnostics Division?
The median time from FDA receipt to decision across 510(k)s cleared under the name Abbott Ireland Diagnostics Division is 424 days. Since 2017: 424 days, versus 242 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Abbott Ireland Diagnostics Division?
The most frequent FDA product codes under this applicant name are CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1); CGX (Alkaline Picrate, Colorimetry, Creatinine, 1); CHH (Enzymatic Esterase--Oxidase, Cholesterol, 1).
Next steps
- See all 8 Abbott Ireland Diagnostics Division clearances with predicates and recalls
- Run predicate analysis for product code CDQ, Abbott Ireland Diagnostics Division'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.