Lumipulse G TSH-III Immunoreaction Cartridges

Radioimmunoassay, Thyroid-stimulating Hormone

Fujirebio Diagnostics, Inc.

The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G Tsh-iii Immunoreaction Cartridges.

Pre-market Notification Details

Device IDK171103
510k NumberK171103
Device Name:Lumipulse G TSH-III Immunoreaction Cartridges
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
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 CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-13
Decision Date2017-07-28
Summary:summary

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