Lumipulse G LH Calibrators

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 Lh Calibrators.

Pre-market Notification Details

Device IDK163521
510k NumberK163521
Device Name:Lumipulse G LH Calibrators
ClassificationCalibrator, Secondary
Applicant FUJIREBIO DIAGNOSTICS, INC 201 GREAT VALLEY PARKWAY Malvern,  PA  19355
ContactDiana Dickson
CorrespondentDiana Dickson
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 Received2016-12-15
Decision Date2017-01-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987270235270 K163521 000
04987270230916 K163521 000

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