K831416 is an FDA 510(k) clearance for the EMIT QST TOBRAMYCIN ASSAY. This device is classified as a Enzyme Immunoassay, Gentamicin (Class II - Special Controls, product code LCD).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983, 36 days after receiving the submission on May 3, 1983.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3450.
| 510(k) Number | K831416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 1983 |
| Decision Date | June 08, 1983 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LCD — Enzyme Immunoassay, Gentamicin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3450 |