K163133

Substantially Equivalent

ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA

Applicant: Immco Diagnostics, Inc.
Product code: DBM
Advisory panel: Immunology
Date received: 2016-11-08
Decision date: 2017-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clarence, NY, US

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