FDA product code MOJ: Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
MOJ is the FDA product code for fluorescence polarization immunoassay, diphenylhydantoin (free). It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel. FDA has cleared 3 510(k) submissions under MOJ, 1 in the last five years, from 3 different applicants. The average 510(k) review took 75 days (median 69).
Classification
| Field | Value |
|---|---|
| Device name | Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free) |
| Device class | Class II |
| Regulation | 21 CFR 862.3350 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MOJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 69 |
Compare with all 510(k) review times · Search every MOJ clearance
Top MOJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics | 1 | 2023-03-30 |
| Roche Diagnostic Systems, Inc. | 1 | 1995-07-31 |
| Abbott Laboratories | 1 | 1995-05-02 |
Most recent MOJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230161 | Roche Diagnostics | ONLINE TDM Phenytoin - Free Phenytoin application | 2023-03-30 | 69 |
| K952555 | Roche Diagnostic Systems, Inc. | COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS | 1995-07-31 | 59 |
| K950280 | Abbott Laboratories | TDX(R)/TDXFLX(R) FREE PHENYTOIN II | 1995-05-02 | 98 |
Recalls for MOJ devices
openFDA lists no recalls for product code MOJ.
Frequently asked questions
What is FDA product code MOJ?
MOJ is the FDA product code for fluorescence polarization immunoassay, diphenylhydantoin (free). It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel.
What device class is MOJ?
Class II, regulation 21 CFR 862.3350. Typical premarket route: 510(k).
How long does a 510(k) take for product code MOJ?
Across 3 cleared submissions the average was 75 days from receipt to decision (median 69).
Which companies have the most MOJ clearances?
Roche Diagnostics (1); Roche Diagnostic Systems, Inc. (1); Abbott Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MOJ
- Run a recall and safety report across every MOJ manufacturer
- Watch product code MOJ 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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