Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators

System, Test, Vitamin D

FUJIREBIO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G 25-oh Vitamin D, Lumipulse G 25-oh Vitamin D Calibrators.

Pre-market Notification Details

Device IDK153361
510k NumberK153361
Device Name:Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
ClassificationSystem, Test, Vitamin D
Applicant FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PARKWAY Malvern,  PA  19355
ContactStacey Dolan
CorrespondentStacey Dolan
FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PARKWAY Malvern,  PA  19355
Product CodeMRG  
CFR Regulation Number862.1825 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-20
Decision Date2016-04-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987270235089 K153361 000
04987270234020 K153361 000

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