Elan Holdings, Inc.: FDA clearances and approvals
Elan Holdings, Inc. has 12 FDA 510(k) clearances (first 1999, latest 2001), across 11 product codes in 1 review panel. Median 510(k) review time: 53 days.
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 |
|---|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | 2 | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 | 1 |
| LBR | Ldl & Vldl Precipitation, Hdl | 1 | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (12)
Most recent Elan Holdings, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013152 | ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS | LBS | 2001-11-09 | 50 |
| K012474 | ATAC PAK CPK REAGENT KIT | CGS | 2001-10-03 | 62 |
| K010488 | ATAC PAK AST REAGENT KIT | CIT | 2001-04-09 | 48 |
| K000958 | ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS | CDQ | 2000-05-24 | 61 |
| K000900 | ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS | CHH | 2000-05-02 | 42 |
| K992844 | HICHEM ISE ELECTROLYTE BUFFER | JGS | 1999-11-26 | 94 |
| K992842 | HICHEM ISE ELECTROLYTE REFERENCE | JGS | 1999-11-26 | 94 |
| K992846 | HICHEM TOTAL PROTEIN REAGENT | CEK | 1999-10-18 | 55 |
| K992845 | HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT | JIX | 1999-10-18 | 55 |
| K992847 | HICHEM BUN REAGENT | LFP | 1999-10-14 | 51 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Elan Holdings, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Elan Holdings, Inc. have?
Elan Holdings, Inc. has 12 FDA 510(k) clearances (first 1999, latest 2001), across 11 product codes in 1 review panel.
How long does FDA take to clear Elan Holdings, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Elan Holdings, Inc.'s cleared 510(k)s is 53 days.
What devices does Elan Holdings, Inc. make?
Its most frequent FDA product codes are JGS (Electrode, Ion Specific, Sodium, 2); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1); CEK (Biuret (Colorimetric), Total Protein, 1).
Has Elan Holdings, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Elan Holdings, Inc. Related entities may recall under other names.
Next steps
- See all 12 Elan Holdings, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JGS, Elan Holdings, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.