ImmunoCAP Specific IgE; ImmunoCAP Allergen F439, Hazelnut; ImmunoCAP Allergen F440, Hazelnut; ImmunoCAP Allergen F441, Walnut; ImmunoCAP Allergen F442, Walnut; ImmunoCAP Allergen F443, Cashew Nut

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 Specific Ige; Immunocap Allergen F439, Hazelnut; Immunocap Allergen F440, Hazelnut; Immunocap Allergen F441, Walnut; Immunocap Allergen F442, Walnut; Immunocap Allergen F443, Cashew Nut.

Pre-market Notification Details

Device IDK150854
510k NumberK150854
Device Name:ImmunoCAP Specific IgE; ImmunoCAP Allergen F439, Hazelnut; ImmunoCAP Allergen F440, Hazelnut; ImmunoCAP Allergen F441, Walnut; ImmunoCAP Allergen F442, Walnut; ImmunoCAP Allergen F443, Cashew Nut
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant PHADIA AB RAPSGATAN 7P Uppsala,  SE 75137
ContactCarina Magnusson
CorrespondentMartin Mann
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 Received2015-03-31
Decision Date2015-12-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07333066011059 K150854 000
07333066011042 K150854 000
07333066011035 K150854 000
07333066011028 K150854 000
07333066011004 K150854 000

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