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510(k) K163133

ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA by Immco Diagnostics, Inc. — Product Code DBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2017
Date Received
November 8, 2016
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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