Lumipulse G ROMA

Ovarian Adnexal Mass Assessment Score Test System

Fujirebio Diagnostics, Inc.

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

Pre-market Notification Details

Device IDK160090
510k NumberK160090
Device Name:Lumipulse G ROMA
ClassificationOvarian Adnexal Mass Assessment Score Test System
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 CodeONX  
CFR Regulation Number866.6050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-15
Decision Date2016-05-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00869164000024 K160090 000
00869164000017 K160090 000

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