K820285 is an FDA 510(k) clearance for the SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY. This device is classified as a Fluorescent Immunoassay Gentamicin (Class II - Special Controls, product code LCQ).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on February 18, 1982, 16 days after receiving the submission on February 2, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3450.
| 510(k) Number | K820285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1982 |
| Decision Date | February 18, 1982 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LCQ — Fluorescent Immunoassay Gentamicin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3450 |