K063243 is an FDA 510(k) clearance for the VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448. This device is classified as a Immunoassay Method, Troponin Subunit (Class II - Special Controls, product code MMI).
Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on December 14, 2007, 414 days after receiving the submission on October 26, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K063243 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2006 |
| Decision Date | December 14, 2007 |
| Days to Decision | 414 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 |