Lumipulse G Prolactin

Calibrator, Secondary

FUJIREBIO DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK163544
510k NumberK163544
Device Name:Lumipulse G Prolactin
ClassificationCalibrator, Secondary
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 CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-16
Decision Date2017-01-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987270235195 K163544 000

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