K143470 is an FDA 510(k) clearance for the Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set. This device is classified as a Test, Fibrinogen (Class II - Special Controls, product code GIS).
Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on January 31, 2016, 422 days after receiving the submission on December 5, 2014.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7340.
| 510(k) Number | K143470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2014 |
| Decision Date | January 31, 2016 |
| Days to Decision | 422 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GIS — Test, Fibrinogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7340 |