Lumipulse G CA15-3

System, Test, Immunological, Antigen, Tumor

Fujirebio Diagnostics, Inc.

The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G Ca15-3.

Pre-market Notification Details

Device IDK192524
510k NumberK192524
Device Name:Lumipulse G CA15-3
ClassificationSystem, Test, Immunological, Antigen, Tumor
Applicant Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern,  PA  19355
ContactKristin Maddaloni
CorrespondentKristin Maddaloni
Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern,  PA  19355
Product CodeMOI  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-13
Decision Date2020-09-04

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.