K953016 is an FDA 510(k) clearance for the AXSYM THEOPHYLLINE II. This device is classified as a Fluorescence Polarization Immunoassay, Theophylline (Class II - Special Controls, product code LGS).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 24, 1995, 56 days after receiving the submission on June 29, 1995.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K953016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 1995 |
| Decision Date | August 24, 1995 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LGS — Fluorescence Polarization Immunoassay, Theophylline |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3880 |