The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Dz-lite Total Beta-hcg Test System.
| Device ID | K163418 |
| 510k Number | K163418 |
| Device Name: | Diazyme DZ-Lite Total Beta-hCG Test System |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | Diazyme Laboratories 12889 Gregg Court Poway, CA 92130 |
| Contact | Abhijit Datta |
| Correspondent | Abhijit Datta Diazyme Laboratories 12889 Gregg Court Poway, CA 92130 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-06 |
| Decision Date | 2017-08-18 |