K041811 is an FDA 510(k) clearance for the ABBOTT AXSYM TROPONIN-I ADV. This device is classified as a Immunoassay Method, Troponin Subunit (Class II - Special Controls, product code MMI).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 10, 2004, 66 days after receiving the submission on July 6, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K041811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2004 |
| Decision Date | September 10, 2004 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MMI — Immunoassay Method, Troponin Subunit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |