K112818 is an FDA 510(k) clearance for the VIDAS D-DIMER EXCLUSION II (DEX2). This device is classified as a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II - Special Controls, product code DAP).
Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on July 31, 2012, 307 days after receiving the submission on September 28, 2011.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7320.
| 510(k) Number | K112818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2011 |
| Decision Date | July 31, 2012 |
| Days to Decision | 307 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | DAP — Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7320 |