K790829 is an FDA 510(k) clearance for the EMIT GENTAMICIN ASSAY. This device is classified as a Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (Class II - Special Controls, product code DJB).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on May 15, 1979, 15 days after receiving the submission on April 30, 1979.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3450.
| 510(k) Number | K790829 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 1979 |
| Decision Date | May 15, 1979 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DJB — Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3450 |