K801084 is an FDA 510(k) clearance for the CYBREX GENTAMICIN. This device is classified as a Fluorescent Immunoassay Gentamicin (Class II - Special Controls, product code LCQ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 23, 1980, 16 days after receiving the submission on May 7, 1980.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3450.
| 510(k) Number | K801084 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 1980 |
| Decision Date | May 23, 1980 |
| 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 |