Lumipulse G TP-N Immunoreaction Cartridge Set

Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

Fujirebio Diagnostics, Inc.

The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G Tp-n Immunoreaction Cartridge Set.

Pre-market Notification Details

Device IDK153145
510k NumberK153145
Device Name:Lumipulse G TP-N Immunoreaction Cartridge Set
ClassificationEnzyme Linked Immunoabsorption Assay, Treponema Pallidum
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 CodeLIP  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-30
Decision Date2016-07-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987270235041 K153145 000

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