EliA Ro52, EliA Ro60

Antinuclear Antibody, Antigen, Control

Phadia AB

The following data is part of a premarket notification filed by Phadia Ab with the FDA for Elia Ro52, Elia Ro60.

Pre-market Notification Details

Device IDK210902
510k NumberK210902
Device Name:EliA Ro52, EliA Ro60
ClassificationAntinuclear Antibody, Antigen, Control
Applicant Phadia AB Rapsgatan 7P Uppsala,  SE
ContactSheryl Skinner
CorrespondentJane R Anthony
Phadia, US Lnc. 4169 Commercial Avenue Portage,  MI  49002
Product CodeLKJ  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-26
Decision Date2022-07-27

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