The following data is part of a premarket notification filed by Shenzhen New Industries Biomedical Engineering Co.,ltd with the FDA for Maglumi 2000 Tsh, Maglumi 2000 Immunoassay Analyzer.
| Device ID | K162698 |
| 510k Number | K162698 |
| Device Name: | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD NO.16, JINHUI RD, 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 | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-27 |
| Decision Date | 2017-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06947145500023 | K162698 | 000 |
| 06947145500016 | K162698 | 000 |