FDA product code LTD: Paraquat Assay
LTD is the FDA product code for paraquat assay. It is a Class III device, reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under LTD, from 2 different applicants. The average 510(k) review took 94 days (median 94). FDA has posted 1 recall for LTD devices.
Classification
| Field | Value |
|---|---|
| Device name | Paraquat Assay |
| Device class | Class III |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Compare with all 510(k) review times · Search every LTD clearance
Top LTD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Austin Biological Laboratories | 1 | 1985-02-19 |
| Analytical Products, Inc. | 1 | 1984-10-24 |
Most recent LTD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K843612 | Austin Biological Laboratories | MODIFICATION OF ABL MIC-10 PRECEPT SYS | 1985-02-19 | 159 |
| K843732 | Analytical Products, Inc. | API UNISCEPT MIC | 1984-10-24 | 30 |
Recalls for LTD devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-06-04.
Frequently asked questions
What is FDA product code LTD?
LTD is the FDA product code for paraquat assay. It is a Class III device, reviewed by the Clinical Toxicology panel.
What device class is LTD?
Class III. Typical premarket route: Contact FDA.
How long does a 510(k) take for product code LTD?
Across 2 cleared submissions the average was 94 days from receipt to decision (median 94).
Which companies have the most LTD clearances?
Austin Biological Laboratories (1); Analytical Products, Inc. (1).
Have LTD devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-06-04.
Next steps
- Run an FDA pathway report with predicate devices for product code LTD
- Run a recall and safety report across every LTD manufacturer
- Watch product code LTD 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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