K033491 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY. This device is classified as a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II - Special Controls, product code DAP).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 1, 2004, 302 days after receiving the submission on November 4, 2003.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7320.
| 510(k) Number | K033491 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2003 |
| Decision Date | September 01, 2004 |
| Days to Decision | 302 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 |