K802669 is an FDA 510(k) clearance for the CYBREX AMIKACIN. This device is classified as a Radioimmunoassay, Amikacin (Class II - Special Controls, product code KLQ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 12, 1980, 16 days after receiving the submission on October 27, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3035.
| 510(k) Number | K802669 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1980 |
| Decision Date | November 12, 1980 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KLQ — Radioimmunoassay, Amikacin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3035 |