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510(k) K182747

EliA RF IgM Immunoassay by Phadia AB — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2018
Date Received
September 28, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
Review Panel
IM
Submission Type

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