K782125 is an FDA 510(k) clearance for the RIA KIT, KANAMYCIN. This device is classified as a Radioimmunoassay, Kanamycin (Class II - Special Controls, product code KJI).
Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on January 10, 1979, 14 days after receiving the submission on December 27, 1978.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3520.
| 510(k) Number | K782125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1978 |
| Decision Date | January 10, 1979 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KJI — Radioimmunoassay, Kanamycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3520 |