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

Name: FDA 510(k) clearance K163133
Creator: U.S. Food and Drug Administration
Published: 2017-08-08

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.. Device class: 2.

Clearance details

Applicant: Immco Diagnostics, Inc.
Product code: Code DBM
Device class: Class 2
Regulation: 21 CFR 866.5090
Advisory panel: Immunology
Date received: 2016-11-08
Decision date: 2017-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clarence, NY, US

Download summary PDF View on FDA.gov ↗

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