FDA product code MLM: Enzyme Immunoassay, Tracrolimus
MLM is the FDA product code for enzyme immunoassay, tracrolimus. It is a Class II device, regulated under 21 CFR 862.1678 and reviewed by the Clinical Toxicology panel. FDA has cleared 9 510(k) submissions under MLM, 1 in the last five years, from 7 different applicants. The average 510(k) review took 230 days (median 147). 2 PMA applications cite this product code. FDA has posted 12 recalls for MLM devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Tracrolimus |
| Device class | Class II |
| Regulation | 21 CFR 862.1678 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MLM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 321 |
| 2023 | 1 | 758 |
Compare with all 510(k) review times · Search every MLM clearance
Top MLM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Microgenics Corp. | 2 | 2013-07-11 |
| Dade Behring, Inc. | 2 | 2006-05-18 |
| Shanghai Genext Medical Technology Co., Ltd. | 1 | 2023-01-27 |
| Roche Diagnostics | 1 | 2018-11-06 |
| Siemens Healthcare Diagnostics | 1 | 2015-11-04 |
2 more applicants have MLM clearances. See the full list in Caduvo.
Most recent MLM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203833 | Shanghai Genext Medical Technology Co., Ltd. | Tacrolimus Assay Kit | 2023-01-27 | 758 |
| K173857 | Roche Diagnostics | Elecsys Tacrolimus | 2018-11-06 | 321 |
| K150168 | Siemens Healthcare Diagnostics | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) | 2015-11-04 | 282 |
| K123343 | Microgenics Corp. | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS | 2013-07-11 | 253 |
| K070820 | Fujirebio Diagnostics,Inc. | ARCHITECT TACROLIMUS: MODEL 1L77 | 2007-08-01 | 128 |
Recalls for MLM devices
12 product recalls in 12 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-05-07.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code MLM?
MLM is the FDA product code for enzyme immunoassay, tracrolimus. It is a Class II device, regulated under 21 CFR 862.1678 and reviewed by the Clinical Toxicology panel.
What device class is MLM?
Class II, regulation 21 CFR 862.1678. Typical premarket route: 510(k).
How long does a 510(k) take for product code MLM?
Across 9 cleared submissions the average was 230 days from receipt to decision (median 147).
Which companies have the most MLM clearances?
Microgenics Corp. (2); Dade Behring, Inc. (2); Shanghai Genext Medical Technology Co., Ltd. (1); Roche Diagnostics (1); Siemens Healthcare Diagnostics (1).
Have MLM devices been recalled?
Yes: 12 product recalls across 12 recall events; the most recent began 2026-05-07.
Next steps
- Run an FDA pathway report with predicate devices for product code MLM
- Run a recall and safety report across every MLM manufacturer
- Watch product code MLM 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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