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510(k) K181556

EliA M2 Immunoassay by Phadia AB — Product Code DBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2018
Date Received
June 13, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5090
Review Panel
IM
Submission Type

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