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510(k) K190710

EliA SymphonyS Immunoassay by Phadia AB — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2019
Date Received
March 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractable Antinuclear Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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