ImmunoCAP Allergen O215, Component NGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, Bovine

System, Test, Radioallergosorbent (rast) Immunological

Phadia AB

The following data is part of a premarket notification filed by Phadia Ab with the FDA for Immunocap Allergen O215, Component Ngal-alpha-1,3-gal(alpha-gal) Thyroglobulin, Bovine.

Pre-market Notification Details

Device IDK200279
510k NumberK200279
Device Name:ImmunoCAP Allergen O215, Component NGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, Bovine
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant Phadia AB Rapsgatan 7P Uppsala,  SE 75137
ContactCarina Magnusson
CorrespondentSheryl Skinner
Phadia US Inc. 4169 Commercial Ave Portage,  MI  49002
Product CodeDHB  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-04
Decision Date2020-05-01

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