KJIClass II
Radioimmunoassay, Kanamycin
21 CFR 862.3520 / Clinical Toxicology
KJI is the FDA product code for Radioimmunoassay, Kanamycin, a class II device type, regulated under 21 CFR 862.3520. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- KJI
- Device name
- Radioimmunoassay, Kanamycin
- Regulation
- 21 CFR 862.3520
- Device class
- Class II
- Review panel
- Clinical Toxicology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 6
- Ingested recalls
- 0
Clearances, product code KJI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 1 |
| 1982 | 3 |
| 1983 | 1 |
Applicants with the most clearances
Product code KJI| Applicant | Clearances |
|---|---|
| Abbott Medical | 1 |
| American Diagnostic Corp. | 1 |
| Siemens Healthcare Diagnostics Inc. | 1 |
| Miles Laboratories, Inc. | 1 |
| Monitor Science Corp. | 1 |
| Syva Co. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code KJI.
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