K953115 is an FDA 510(k) clearance for the AXSYM AMPHETAMINE/METHAMPHETAMINE II. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 6, 1995, 95 days after receiving the submission on July 3, 1995.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K953115 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 1995 |
| Decision Date | October 06, 1995 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DKZ — Enzyme Immunoassay, Amphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |