Elan Diagnostics: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Elan Diagnostics” (first 1999, latest 2003), across 12 product codes in 1 review panel. Median 510(k) review time under this name: 67 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| JGJ | Photometric Method, Magnesium | 1 | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 | 1 |
Plus 2 more product codes.
Review panels
- Clinical Chemistry (13)
Most recent Elan Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030003 | ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR | CIG | 2003-09-29 | 270 |
| K030014 | ATAC TOTAL BILIRUBIN REAGENT | CIG | 2003-09-26 | 267 |
| K030621 | ATAC CALIBRATOR | JIX | 2003-03-19 | 20 |
| K023105 | ATAC CALCIUM REAGENT AND ATAC CALIBRATOR | CIC | 2003-03-13 | 176 |
| K030010 | ATAC PAK MAGNESIUM REAGENT | JGJ | 2003-03-10 | 67 |
| K030015 | ATAC PAK PHOSPHORUS REAGENT | CEO | 2003-03-07 | 64 |
| K030006 | ATAC PAK ALBUMIN REAGENT | CIX | 2003-03-07 | 64 |
| K023407 | ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR | CGX | 2003-02-14 | 127 |
| K021385 | ATAC PAK BUN REAGENT | CDQ | 2002-07-12 | 71 |
| K020575 | ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS | MRR | 2002-04-12 | 50 |
3 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2002-11-07.
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.
- Elan Holdings, Inc. (12 510(k)s)
- Elan Pharma, Inc. (4 510(k)s)
- Elan Medical Technologies, Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Elan Diagnostics?
FDA lists 13 510(k) clearances under the applicant name “Elan Diagnostics” (first 1999, latest 2003), across 12 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 Elan Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Elan Diagnostics is 67 days.
Which FDA product codes appear under Elan Diagnostics?
The most frequent FDA product codes under this applicant name are CIG (Diazo Colorimetry, Bilirubin, 2); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1); CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus, 1).
Next steps
- See all 13 Elan Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code CIG, Elan Diagnostics'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.