FDA product code LOO: Reagent, Leishmanii Serological
LOO is the FDA product code for reagent, leishmanii serological. It is a Class I device, regulated under 21 CFR 866.3870 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under LOO, from 2 different applicants. The average 510(k) review took 131 days (median 131).
Classification
| Field | Value |
|---|---|
| Device name | Reagent, Leishmanii Serological |
| Device class | Class I |
| Regulation | 21 CFR 866.3870 |
| 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 LOO clearance
Top LOO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inbios Intl., Inc. | 1 | 2003-05-06 |
| Amico Lab, Inc. | 1 | 1984-08-28 |
Most recent LOO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023483 | Inbios Intl., Inc. | KALAZAR DETECT | 2003-05-06 | 201 |
| K842526 | Amico Lab, Inc. | AMIZYME-LEISHMANIA SPP. TEST KIT | 1984-08-28 | 61 |
Recalls for LOO devices
openFDA lists no recalls for product code LOO.
Frequently asked questions
What is FDA product code LOO?
LOO is the FDA product code for reagent, leishmanii serological. It is a Class I device, regulated under 21 CFR 866.3870 and reviewed by the Microbiology panel.
What device class is LOO?
Class I, regulation 21 CFR 866.3870. Typical premarket route: 510(k).
How long does a 510(k) take for product code LOO?
Across 2 cleared submissions the average was 131 days from receipt to decision (median 131).
Which companies have the most LOO clearances?
Inbios Intl., Inc. (1); Amico Lab, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LOO
- Run a recall and safety report across every LOO manufacturer
- Watch product code LOO 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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