K032419 is an FDA 510(k) clearance for the QUANTEX D-DIMER. This device is classified as a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II - Special Controls, product code DAP).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on October 24, 2003, 80 days after receiving the submission on August 5, 2003.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7320.
| 510(k) Number | K032419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2003 |
| Decision Date | October 24, 2003 |
| Days to Decision | 80 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 |