The following data is part of a premarket notification filed by Shenzhen New Industries Biomedical Engineering Co., Ltd with the FDA for Maglumi 2000 Ft4.
| Device ID | K182423 |
| 510k Number | K182423 |
| Device Name: | MAGLUMI 2000 FT4 |
| Classification | Radioimmunoassay, Free Thyroxine |
| 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 | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-06 |
| Decision Date | 2018-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06947145577988 | K182423 | 000 |
| 06947145577971 | K182423 | 000 |