IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA— 510(k) K091520

Substantially Equivalent

Immco Diagnostics, Inc.

FDA 510(k) clearance K091520 for IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA, Substantially Equivalent on 2010-03-10. Applicant: Immco Diagnostics, Inc..

Clearance details

Applicant: Immco Diagnostics, Inc.
Product code: Code MVM
Advisory panel: Immunology
Date received: 2009-05-22
Decision date: 2010-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

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