The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G Whole Pth.
| Device ID | K190702 |
| 510k Number | K190702 |
| Device Name: | Lumipulse G Whole PTH |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | Fujirebio Diagnostics, Inc. 201 Great Valley Pkwy Malvern, PA 19355 |
| Contact | Stacey Dolan |
| Correspondent | Stacey Dolan Fujirebio Diagnostics, Inc. 201 Great Valley Pkwy Malvern, PA 19355 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-18 |
| Decision Date | 2019-08-30 |