K963158 is an FDA 510(k) clearance for the ABBOTT AXSYM DIGITOXIN (MODIFY). 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 September 10, 1996, 46 days after receiving the submission on July 26, 1996.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3300.
| 510(k) Number | K963158 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 1996 |
| Decision Date | September 10, 1996 |
| Days to Decision | 46 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 |