ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA— 510(k) K162788

Substantially Equivalent

Immco Diagnostics, Inc.

FDA 510(k) clearance K162788 for ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA, Substantially Equivalent on 2017-06-19. Applicant: Immco Diagnostics, Inc..

Clearance details

Applicant: Immco Diagnostics, Inc.
Product code: Code MSV
Advisory panel: Immunology
Date received: 2016-10-03
Decision date: 2017-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clarence, NY, US

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