K820440 is an FDA 510(k) clearance for the EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO. This device is classified as a Enzymatic Radiochemical Assay, Amikacin (Class II - Special Controls, product code LDN).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1982, 26 days after receiving the submission on February 17, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3035.
| 510(k) Number | K820440 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 1982 |
| Decision Date | March 15, 1982 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LDN — Enzymatic Radiochemical Assay, Amikacin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3035 |