FDA product code MRR: System, Test, Low Density, Lipoprotein
MRR is the FDA product code for system, test, low density, lipoprotein. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel. FDA has cleared 31 510(k) submissions under MRR, 2 in the last five years, from 26 different applicants. The average 510(k) review took 139 days (median 72); 35 days on average over the last three years. FDA has posted 9 recalls for MRR devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Low Density, Lipoprotein |
| Device class | Class I |
| Regulation | 21 CFR 862.1475 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
510(k) clearances per year for MRR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 273 |
| 2023 | 1 | 854 |
| 2024 | 1 | 35 |
Compare with all 510(k) review times · Search every MRR clearance
Top MRR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Reference Diagnostics, Inc. | 4 | 1999-01-28 |
| Genzyme Corp. | 3 | 1999-10-18 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 2024-07-26 |
| Numares AG | 1 | 2023-07-19 |
| Randox Laboratories Limited | 1 | 2017-03-20 |
21 more applicants have MRR clearances. See the full list in Caduvo.
Most recent MRR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241800 | Siemens Healthcare Diagnostics, Inc. | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) | 2024-07-26 | 35 |
| K210801 | Numares AG | AXINON® LDL-p Test System | 2023-07-19 | 854 |
| K161691 | Randox Laboratories Limited | Direct LDL Cholesterol (LDL) | 2017-03-20 | 273 |
| K091333 | Alfa Wassermann, Inc. | S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 | 2009-08-03 | 89 |
| K090734 | Medica Corp. | EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES | 2009-07-17 | 120 |
Recalls for MRR devices
9 product recalls in 9 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-09-17.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2023 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MRR?
MRR is the FDA product code for system, test, low density, lipoprotein. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel.
What device class is MRR?
Class I, regulation 21 CFR 862.1475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MRR?
Across 31 cleared submissions the average was 139 days from receipt to decision (median 72).
Which companies have the most MRR clearances?
Reference Diagnostics, Inc. (4); Genzyme Corp. (3); Siemens Healthcare Diagnostics, Inc. (1); Numares AG (1); Randox Laboratories Limited (1).
Have MRR devices been recalled?
Yes: 9 product recalls across 9 recall events; the most recent began 2025-09-17.
Next steps
- Run an FDA pathway report with predicate devices for product code MRR
- Run a recall and safety report across every MRR manufacturer
- Watch product code MRR 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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