The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G Ca15-3.
Device ID | K192524 |
510k Number | K192524 |
Device Name: | Lumipulse G CA15-3 |
Classification | System, Test, Immunological, Antigen, Tumor |
Applicant | Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
Contact | Kristin Maddaloni |
Correspondent | Kristin Maddaloni Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
Product Code | MOI |
CFR Regulation Number | 866.6010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-13 |
Decision Date | 2020-09-04 |