ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA— 510(k) K143736

Name: FDA 510(k) clearance K143736
Creator: U.S. Food and Drug Administration
Published: 2015-09-23

Substantially Equivalent

Immco Diagnostics, Inc.

FDA 510(k) clearance K143736 for ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA, Substantially Equivalent on 2015-09-23. Applicant: Immco Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Immco Diagnostics, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 2014-12-30
Decision date: 2015-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clarence, NY, US

Download summary PDF View on FDA.gov ↗

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