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 |