EliA SmDP-S

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-s.

Pre-market Notification Details

Device IDK202067
510k NumberK202067
Device Name:EliA SmDP-S
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 Received2020-07-27
Decision Date2021-07-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07333066017709 K202067 000

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