K931123 is an FDA 510(k) clearance for the DIGOXIN TEST SYSTEM, KXT TX. This device is classified as a Enzyme Immunoassay, Digoxin (Class II - Special Controls, product code KXT).
Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on August 5, 1993, 154 days after receiving the submission on March 4, 1993.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K931123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1993 |
| Decision Date | August 05, 1993 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | KXT — Enzyme Immunoassay, Digoxin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |