K802668 is an FDA 510(k) clearance for the CYBREX TOBRAMYCIN. This device is classified as a Fluorescent Immunoassay, Tobramycin (Class II - Special Controls, product code LCR).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 24, 1980, 28 days after receiving the submission on October 27, 1980.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3900.
| 510(k) Number | K802668 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1980 |
| Decision Date | November 24, 1980 |
| Days to Decision | 28 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 |