K904226 is an FDA 510(k) clearance for the 'TDXFLX ANALYZER. 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 October 29, 1990, 46 days after receiving the submission on September 13, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3450.
| 510(k) Number | K904226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 1990 |
| Decision Date | October 29, 1990 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LCQ — Fluorescent Immunoassay Gentamicin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3450 |