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.
Device ID | K150854 |
510k Number | K150854 |
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 |
Classification | System, Test, Radioallergosorbent (rast) Immunological |
Applicant | PHADIA AB RAPSGATAN 7P Uppsala, SE 75137 |
Contact | Carina Magnusson |
Correspondent | Martin Mann PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
Product Code | DHB |
CFR Regulation Number | 866.5750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-31 |
Decision Date | 2015-12-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07333066011059 | K150854 | 000 |
07333066011042 | K150854 | 000 |
07333066011035 | K150854 | 000 |
07333066011028 | K150854 | 000 |
07333066011004 | K150854 | 000 |