EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay— 510(k) K181871

Substantially Equivalent

Phadia AB

FDA 510(k) clearance K181871 for EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay, Substantially Equivalent on 2019-03-01. Applicant: Phadia AB.

Clearance details

Applicant
Phadia AB
Product code
Code MVM
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Uppsala, SE
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