Lumipulse G Whole PTH

Radioimmunoassay, Parathyroid Hormone

Fujirebio Diagnostics, Inc.

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

Pre-market Notification Details

Device IDK190702
510k NumberK190702
Device Name:Lumipulse G Whole PTH
ClassificationRadioimmunoassay, Parathyroid Hormone
Applicant Fujirebio Diagnostics, Inc. 201 Great Valley Pkwy Malvern,  PA  19355
ContactStacey Dolan
CorrespondentStacey Dolan
Fujirebio Diagnostics, Inc. 201 Great Valley Pkwy Malvern,  PA  19355
Product CodeCEW  
CFR Regulation Number862.1545 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-18
Decision Date2019-08-30

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