K030328 is an FDA 510(k) clearance for the VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442. 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 September 2, 2003, 214 days after receiving the submission on January 31, 2003.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7320.
| 510(k) Number | K030328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2003 |
| Decision Date | September 02, 2003 |
| Days to Decision | 214 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 |