Lumipulse G E2-III 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 E2-iii Calibrators.

Pre-market Notification Details

Device IDK163053
510k NumberK163053
Device Name:Lumipulse G E2-III Calibrators
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 Received2016-11-01
Decision Date2016-12-01
Summary:summary

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