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510(k) K182353

EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay by Phadia AB — Product Code LJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2018
Date Received
August 29, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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