ImmunoCAP Allergen D202, Allergen Component RDer P 1,House Dust Mite

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 D202, Allergen Component Rder P 1,house Dust Mite.

Pre-market Notification Details

Device IDK150597
510k NumberK150597
Device Name:ImmunoCAP Allergen D202, Allergen Component RDer P 1,House Dust Mite
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant PHADIA AB RAPSGATAN 7P Uppsala,  SE 75137
ContactCarina Magnusson
CorrespondentMartin Mann
Phadia US Inc. 4169 Commerical Avenue Portage,  MI  49002
Product CodeDHB  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-09
Decision Date2016-02-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07333066011073 K150597 000

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