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 |