510(k) K142781— ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA

Substantially Equivalent

Immco Diagnostics, Inc.

Clearance details

Applicant: Immco Diagnostics, Inc.
Product code: Code LLL
Advisory panel: Immunology
Date received: 2014-09-26
Decision date: 2015-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clarence, NY, US

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