EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay— 510(k) K173792

Substantially Equivalent

Phadia AB

FDA 510(k) clearance K173792 for EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay, Substantially Equivalent on 2018-03-13. Applicant: Phadia AB.

Clearance details

Applicant: Phadia AB
Product code: Code MOB
Advisory panel: Immunology
Date received: 2017-12-14
Decision date: 2018-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

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