FDA product code KTO: Reagent, Immunoassay, Igg
KTO is the FDA product code for reagent, immunoassay, igg. It is a Class I device, regulated under 21 CFR 866.5530 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under KTO, from 2 different applicants. The average 510(k) review took 24 days (median 24). FDA has posted 2 recalls for KTO devices.
Classification
| Field | Value |
|---|---|
| Device name | Reagent, Immunoassay, Igg |
| Device class | Class I |
| Regulation | 21 CFR 866.5530 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KTO clearance
Top KTO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Reagents Applications, Inc. | 1 | 1989-08-01 |
| Kallestad Laboratories, Inc. | 1 | 1985-12-11 |
Most recent KTO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K894416 | Reagents Applications, Inc. | RAICHEM(TM) SPIA(TM) IGG REAGENTS | 1989-08-01 | 15 |
| K854483 | Kallestad Laboratories, Inc. | KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT | 1985-12-11 | 34 |
Recalls for KTO devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-12-22.
Frequently asked questions
What is FDA product code KTO?
KTO is the FDA product code for reagent, immunoassay, igg. It is a Class I device, regulated under 21 CFR 866.5530 and reviewed by the Immunology panel.
What device class is KTO?
Class I, regulation 21 CFR 866.5530. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KTO?
Across 2 cleared submissions the average was 24 days from receipt to decision (median 24).
Which companies have the most KTO clearances?
Reagents Applications, Inc. (1); Kallestad Laboratories, Inc. (1).
Have KTO devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2014-12-22.
Next steps
- Run an FDA pathway report with predicate devices for product code KTO
- Run a recall and safety report across every KTO manufacturer
- Watch product code KTO 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.
All Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times