EliA SmDP Immunoassay

Anti-sm Antibody, Antigen And Control

Phadia AB

The following data is part of a premarket notification filed by Phadia Ab with the FDA for Elia Smdp Immunoassay.

Pre-market Notification Details

Device IDK183007
510k NumberK183007
Device Name:EliA SmDP Immunoassay
ClassificationAnti-sm Antibody, Antigen And Control
Applicant Phadia AB Rapsgatan 7P Uppsala,  SE Se 754 50
ContactCarina Magnusson
CorrespondentSheryl Skinner
Phadia US Inc. 4169 Commercial Avenue Portage,  MI  49002
Product CodeLKP  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-31
Decision Date2018-12-24
Summary:summary

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