FDA product code DIY: Gas Chromatography, Ethosuximide
DIY is the FDA product code for gas chromatography, ethosuximide. It is a Class II device, regulated under 21 CFR 862.3380 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DIY. The average 510(k) review took 51 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Gas Chromatography, Ethosuximide |
| Device class | Class II |
| Regulation | 21 CFR 862.3380 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DIY clearance
Top DIY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vitek Systems, Inc. | 1 | 1978-06-22 |
Most recent DIY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K780734 | Vitek Systems, Inc. | ANTICONVULSANTS II CALIBRATOR KIT | 1978-06-22 | 51 |
Recalls for DIY devices
openFDA lists no recalls for product code DIY.
Frequently asked questions
What is FDA product code DIY?
DIY is the FDA product code for gas chromatography, ethosuximide. It is a Class II device, regulated under 21 CFR 862.3380 and reviewed by the Clinical Toxicology panel.
What device class is DIY?
Class II, regulation 21 CFR 862.3380. Typical premarket route: 510(k).
How long does a 510(k) take for product code DIY?
Across 1 cleared submissions the average was 51 days from receipt to decision (median 51).
Which companies have the most DIY clearances?
Vitek Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DIY
- Run a recall and safety report across every DIY manufacturer
- Watch product code DIY 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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