K955422 is an FDA 510(k) clearance for the AXSYM N-ACETYLPROCAINAMIDE. This device is classified as a Enzyme Immunoassay, N-acetylprocainamide (Class II - Special Controls, product code LAN).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 24, 1996, 148 days after receiving the submission on November 28, 1995.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K955422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 1995 |
| Decision Date | April 24, 1996 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LAN — Enzyme Immunoassay, N-acetylprocainamide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |