K833546 is an FDA 510(k) clearance for the MODIFICATION OF EMIT AND AMIKACIN ASSAY. 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 December 8, 1983, 55 days after receiving the submission on October 14, 1983.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3035.
| 510(k) Number | K833546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1983 |
| Decision Date | December 08, 1983 |
| Days to Decision | 55 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 |