FDA product code LTX: Discs, Elution
LTX is the FDA product code for discs, elution. It is a Class II device, regulated under 21 CFR 866.1620 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under LTX. The average 510(k) review took 92 days (median 92). 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Discs, Elution |
| Device class | Class II |
| Regulation | 21 CFR 866.1620 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LTX clearance
Top LTX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ab Biodisk | 2 | 2000-11-08 |
Most recent LTX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K002139 | Ab Biodisk | ETEST LINEZOLID | 2000-11-08 | 114 |
| K992993 | Ab Biodisk | ETEST FOR QUINUPRISTIN/DALFOPRISTIN | 1999-11-16 | 70 |
Recalls for LTX devices
openFDA lists no recalls for product code LTX.
Frequently asked questions
What is FDA product code LTX?
LTX is the FDA product code for discs, elution. It is a Class II device, regulated under 21 CFR 866.1620 and reviewed by the Microbiology panel.
What device class is LTX?
Class II, regulation 21 CFR 866.1620. Typical premarket route: 510(k).
How long does a 510(k) take for product code LTX?
Across 2 cleared submissions the average was 92 days from receipt to decision (median 92).
Which companies have the most LTX clearances?
Ab Biodisk (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LTX
- Run a recall and safety report across every LTX manufacturer
- Watch product code LTX 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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