IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA— 510(k) K091522

Substantially Equivalent

Immco Diagnostics, Inc.

FDA 510(k) clearance K091522 for IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA, Substantially Equivalent on 2010-02-04. Applicant: Immco Diagnostics, Inc..

Clearance details

Applicant: Immco Diagnostics, Inc.
Product code: Code MST
Advisory panel: Immunology
Date received: 2009-05-22
Decision date: 2010-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

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