K893843 is an FDA 510(k) clearance for the EZ-BEAD DIGOXIN EIA KIT. This device is classified as a Enzyme Immunoassay, Digoxin (Class II - Special Controls, product code KXT).
Submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on September 28, 1989, 126 days after receiving the submission on May 25, 1989.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K893843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 1989 |
| Decision Date | September 28, 1989 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KXT — Enzyme Immunoassay, Digoxin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |