K163418 is an FDA 510(k) clearance for the Diazyme DZ-Lite Total beta-hCG Test System. This device is classified as a System, Test, Human Chorionic Gonadotropin (Class II - Special Controls, product code DHA).
Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on August 18, 2017, 255 days after receiving the submission on December 6, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K163418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2016 |
| Decision Date | August 18, 2017 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | DHA — System, Test, Human Chorionic Gonadotropin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |