ImmunoCAP Allergen E229, Allergen Component RCan F 4 Dog, ImmunoCAP Allergen E230, Allergen Component RCan F 6 Dog, ImmunoCAP Allergen E231, Allergen Component RFel D 7 Cat

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 E229, Allergen Component Rcan F 4 Dog, Immunocap Allergen E230, Allergen Component Rcan F 6 Dog, Immunocap Allergen E231, Allergen Component Rfel D 7 Cat.

Pre-market Notification Details

Device IDK190315
510k NumberK190315
Device Name:ImmunoCAP Allergen E229, Allergen Component RCan F 4 Dog, ImmunoCAP Allergen E230, Allergen Component RCan F 6 Dog, ImmunoCAP Allergen E231, Allergen Component RFel D 7 Cat
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant Phadia AB Rapsgatan 7P Uppsala,  SE 75137
ContactUlf Karlberg
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 Received2019-02-13
Decision Date2019-05-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07333066016924 K190315 000
07333066016917 K190315 000
07333066011011 K190315 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.