FDA product code KJI: Radioimmunoassay, Kanamycin
KJI is the FDA product code for radioimmunoassay, kanamycin. It is a Class II device, regulated under 21 CFR 862.3520 and reviewed by the Clinical Toxicology panel. FDA has cleared 6 510(k) submissions under KJI, from 6 different applicants. The average 510(k) review took 34 days (median 23).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Kanamycin |
| Device class | Class II |
| Regulation | 21 CFR 862.3520 |
| 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 KJI clearance
Top KJI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Miles Laboratories, Inc. | 1 | 1983-09-29 |
| Syva Co. | 1 | 1982-12-03 |
| American Diagnostic Corp. | 1 | 1982-11-10 |
| Abbott Laboratories | 1 | 1982-10-08 |
| Diagnostic Products Corp. | 1 | 1979-01-10 |
1 more applicants have KJI clearances. See the full list in Caduvo.
Most recent KJI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832769 | Miles Laboratories, Inc. | AMES TDA KANAMYCIN TEST-CONTROL SERUM | 1983-09-29 | 44 |
| K823370 | Syva Co. | ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY | 1982-12-03 | 23 |
| K823062 | American Diagnostic Corp. | KENAMYCIN FLUORESCENT IMMUNOASSAY FIA | 1982-11-10 | 23 |
| K822808 | Abbott Laboratories | TDX KENAMYCIN | 1982-10-08 | 21 |
| K782125 | Diagnostic Products Corp. | RIA KIT, KANAMYCIN | 1979-01-10 | 14 |
Recalls for KJI devices
openFDA lists no recalls for product code KJI.
Frequently asked questions
What is FDA product code KJI?
KJI is the FDA product code for radioimmunoassay, kanamycin. It is a Class II device, regulated under 21 CFR 862.3520 and reviewed by the Clinical Toxicology panel.
What device class is KJI?
Class II, regulation 21 CFR 862.3520. Typical premarket route: 510(k).
How long does a 510(k) take for product code KJI?
Across 6 cleared submissions the average was 34 days from receipt to decision (median 23).
Which companies have the most KJI clearances?
Miles Laboratories, Inc. (1); Syva Co. (1); American Diagnostic Corp. (1); Abbott Laboratories (1); Diagnostic Products Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KJI
- Run a recall and safety report across every KJI manufacturer
- Watch product code KJI 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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