K820130 is an FDA 510(k) clearance for the ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY. This device is classified as a Fluorescent Immunoassay, Tobramycin (Class II - Special Controls, product code LCR).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1982, 18 days after receiving the submission on January 18, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3900.
| 510(k) Number | K820130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 1982 |
| Decision Date | February 05, 1982 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LCR — Fluorescent Immunoassay, Tobramycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3900 |