ImmuLisa Enhanced Centromere Antibody ELISA— 510(k) K151559

Substantially Equivalent

Immco Diagnostics, Inc.

FDA 510(k) clearance K151559 for ImmuLisa Enhanced Centromere Antibody ELISA, Substantially Equivalent on 2016-03-11. Applicant: Immco Diagnostics, Inc..

Clearance details

Applicant: Immco Diagnostics, Inc.
Product code: Code LJM
Advisory panel: Immunology
Date received: 2015-06-10
Decision date: 2016-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

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