IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS

System, Test, Radioallergosorbent (rast) Immunological

PHADIA US INC.

The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Immunocap Specific Ige Allergen Bundle, 12 Allergen Components.

Pre-market Notification Details

Device IDK111919
510k NumberK111919
Device Name:IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant PHADIA US INC. 4169 COMMERCIAL AVE. Portage,  MI  49002
ContactMartin Mann
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 Received2011-07-07
Decision Date2011-12-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07333066010533 K111919 000
07333066005706 K111919 000
07333066008738 K111919 000
07333066008752 K111919 000
07333066008844 K111919 000
07333066008868 K111919 000
07333066009599 K111919 000
07333066009636 K111919 000
07333066009650 K111919 000
07333066009698 K111919 000
07333066010441 K111919 000
07333066005584 K111919 000

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