FDA product code MSL: System, Test, Topiramatee
MSL is the FDA product code for system, test, topiramatee. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under MSL. The average 510(k) review took 90 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Topiramatee |
| Device class | Class II |
| Regulation | 21 CFR 862.3350 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every MSL clearance
Top MSL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oxis Intl., Inc. | 1 | 1997-05-12 |
Most recent MSL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970510 | Oxis Intl., Inc. | INNOFLOUR TOPIRAMATE REAGENT SET | 1997-05-12 | 90 |
Recalls for MSL devices
openFDA lists no recalls for product code MSL.
Frequently asked questions
What is FDA product code MSL?
MSL is the FDA product code for system, test, topiramatee. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel.
What device class is MSL?
Class II, regulation 21 CFR 862.3350. Typical premarket route: 510(k).
How long does a 510(k) take for product code MSL?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most MSL clearances?
Oxis Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MSL
- Run a recall and safety report across every MSL manufacturer
- Watch product code MSL 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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