K950915 is an FDA 510(k) clearance for the ABBOTT AXSYM II SYSTEM. This device is classified as a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I - General Controls, product code JJE).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 16, 1995, 76 days after receiving the submission on March 1, 1995.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2160.
| 510(k) Number | K950915 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1995 |
| Decision Date | May 16, 1995 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2160 |