K954420 is an FDA 510(k) clearance for the AXSYM DIGITOXIN. This device is classified as a Enzyme Immunoassay, Digitoxin (Class II - Special Controls, product code LFM).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 29, 1995, 99 days after receiving the submission on September 21, 1995.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3300.
| 510(k) Number | K954420 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 1995 |
| Decision Date | December 29, 1995 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LFM — Enzyme Immunoassay, Digitoxin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3300 |