K112120 is an FDA 510(k) clearance for the DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET. This device is classified as a Fibrin Split Products (Class II - Special Controls, product code GHH).
Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on January 24, 2013, 549 days after receiving the submission on July 25, 2011.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7320.
| 510(k) Number | K112120 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2011 |
| Decision Date | January 24, 2013 |
| Days to Decision | 549 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GHH — Fibrin Split Products |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7320 |