Randox Laboratories Limited: FDA clearances and approvals
Randox Laboratories Limited has 18 FDA 510(k) clearances (first 2004, latest 2026), across 9 product codes in 2 review panels. Median 510(k) review time: 184 days. Since 2017 its median was 318 days, against 115 days for all cleared 510(k)s in the same product codes. openFDA lists 13 product recalls by a recalling firm named Randox Laboratories Limited.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 248 |
| 2013 | 1 | 128 |
| 2014 | 4 | 60 |
| 2015 | 1 | 132 |
| 2016 | 2 | 172 |
| 2017 | 2 | 262 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 544 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 318 |
Review time against the same product codes
Since 2017, Randox Laboratories Limited's cleared 510(k)s took a median 318 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 6 | 6 |
| DJG | Enzyme Immunoassay, Opiates | 4 | 4 |
| JFM | Enzymatic Method, Bilirubin | 2 | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| JIS | Calibrator, Primary | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | 1 |
| MRR | System, Test, Low Density, Lipoprotein | 1 | 1 |
Review panels
Most recent Randox Laboratories Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex | DJG | 2026-01-23 | 318 |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlex | DJG | 2023-10-05 | 492 |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | DJG | 2023-10-05 | 595 |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP) | CJE | 2017-04-21 | 252 |
| K161691 | Direct LDL Cholesterol (LDL) | MRR | 2017-03-20 | 273 |
| K152343 | Direct Bilirubin | JFM | 2016-02-16 | 181 |
| K152344 | Total Bilirubin | JFM | 2016-01-28 | 162 |
| K150819 | Triglycerides | CDT | 2015-08-06 | 132 |
| K140971 | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. | JJY | 2014-12-08 | 236 |
| K142181 | RANDOX ALDOLASE CALIBRATION SERUM | JIT | 2014-09-18 | 41 |
8 earlier clearances. See the full list in Caduvo.
Recalls
13 product recalls in 9 recall events; 2 initiated in the last five years. Most recent: 2024-12-20.
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 Randox Laboratories Limited have?
Randox Laboratories Limited has 18 FDA 510(k) clearances (first 2004, latest 2026), across 9 product codes in 2 review panels.
How long does FDA take to clear Randox Laboratories Limited's 510(k)s?
The median time from FDA receipt to decision across Randox Laboratories Limited's cleared 510(k)s is 184 days. Since 2017: 318 days, versus 115 days for all cleared 510(k)s in the same product codes.
What devices does Randox Laboratories Limited make?
Its most frequent FDA product codes are JJY (Multi-Analyte Controls, All Kinds (Assayed), 6); DJG (Enzyme Immunoassay, Opiates, 4); JFM (Enzymatic Method, Bilirubin, 2).
Has Randox Laboratories Limited had device recalls?
openFDA lists 13 product recalls in 9 recall events by a recalling firm whose name matches Randox Laboratories Limited; the most recent began 2024-12-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 18 Randox Laboratories Limited clearances with predicates and recalls
- Run predicate analysis for product code JJY, Randox Laboratories Limited'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.