FDA product code MRG: System, Test, Vitamin D
MRG is the FDA product code for system, test, vitamin d. It is a Class II device, regulated under 21 CFR 862.1825 and reviewed by the Clinical Chemistry panel. FDA has cleared 46 510(k) submissions under MRG, 3 in the last five years, from 22 different applicants. The average 510(k) review took 182 days (median 150); 231 days on average over the last three years. FDA has posted 25 recalls for MRG devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Vitamin D |
| Device class | Class II |
| Regulation | 21 CFR 862.1825 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MRG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 145 |
| 2018 | 2 | 108 |
| 2019 | 1 | 56 |
| 2020 | 1 | 88 |
| 2021 | 1 | 159 |
| 2023 | 2 | 258 |
| 2024 | 1 | 231 |
Compare with all 510(k) review times · Search every MRG clearance
Top MRG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immunodiagnostic Systems , Ltd. | 8 | 2016-11-15 |
| DiaSorin, Inc. | 6 | 2014-12-10 |
| Diazyme Laboratories | 4 | 2018-01-11 |
| Beckman Coulter, Inc. | 3 | 2023-01-19 |
| Roche Diagnostics | 3 | 2021-09-01 |
17 more applicants have MRG clearances. See the full list in Caduvo.
Most recent MRG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232587 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer | 2024-04-12 | 231 |
| K221817 | Immunostics Inc., | ALFIS Vitamin D, ALFIS-3 Analyzer | 2023-09-22 | 457 |
| K223503 | Beckman Coulter, Inc. | Access 25(OH) Vitamin D Total | 2023-01-19 | 58 |
| K210901 | Roche Diagnostics | Elecsys Vitamin D total III | 2021-09-01 | 159 |
| K200509 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur Vitamin D Total (VitD) | 2020-05-29 | 88 |
Recalls for MRG devices
25 product recalls in 19 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 4 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code MRG?
MRG is the FDA product code for system, test, vitamin d. It is a Class II device, regulated under 21 CFR 862.1825 and reviewed by the Clinical Chemistry panel.
What device class is MRG?
Class II, regulation 21 CFR 862.1825. Typical premarket route: 510(k).
How long does a 510(k) take for product code MRG?
Across 46 cleared submissions the average was 182 days from receipt to decision (median 150).
Which companies have the most MRG clearances?
Immunodiagnostic Systems , Ltd. (8); DiaSorin, Inc. (6); Diazyme Laboratories (4); Beckman Coulter, Inc. (3); Roche Diagnostics (3).
Have MRG devices been recalled?
Yes: 25 product recalls across 19 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code MRG
- Run a recall and safety report across every MRG manufacturer
- Watch product code MRG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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