The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G Tsh-iii Immunoreaction Cartridges.
| Device ID | K171103 |
| 510k Number | K171103 |
| Device Name: | Lumipulse G TSH-III Immunoreaction Cartridges |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
| Contact | Stacey Dolan |
| Correspondent | Stacey Dolan Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-13 |
| Decision Date | 2017-07-28 |
| Summary: | summary |