DeviceClearance

ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA— 510(k) K163133

Substantially Equivalent

Immco Diagnostics, Inc.

FDA 510(k) clearance K163133 for ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA, Substantially Equivalent on 2017-08-08. Applicant: Immco Diagnostics, Inc..

Clearance details

Applicant
Immco Diagnostics, Inc.
Product code
Code DBM
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Clarence, NY, US
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