K823370 is an FDA 510(k) clearance for the ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY. This device is classified as a Radioimmunoassay, Kanamycin (Class II - Special Controls, product code KJI).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1982, 23 days after receiving the submission on November 10, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3520.
| 510(k) Number | K823370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1982 |
| Decision Date | December 03, 1982 |
| Days to Decision | 23 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 |