The following data is part of a premarket notification filed by Shenzhen New Industries Biomedical Engineering Co., Ltd with the FDA for Maglumi 2000 Hcg/ß-hcg.
| Device ID | K192547 |
| 510k Number | K192547 |
| Device Name: | MAGLUMI 2000 HCG/ß-HCG |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | Shenzhen New Industries Biomedical Engineering Co., Ltd No.16, Jinhui Road, Pingshan New District Shenzhen, CN 518122 |
| Contact | Jie Rao |
| Correspondent | Joe Shia LSI International Inc 504E Diamond Ave., Suite F Gaithersburg, MD 20877 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-17 |
| Decision Date | 2020-01-17 |