K182353

Substantially Equivalent

EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay

Applicant: Phadia AB
Product code: LJM
Advisory panel: Immunology
Date received: 2018-08-29
Decision date: 2018-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

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