IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS— 510(k) K113020

Substantially Equivalent

Immco Diagnostics, Inc.

FDA 510(k) clearance K113020 for IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS, Substantially Equivalent on 2012-10-25. Applicant: Immco Diagnostics, Inc..

Clearance details

Applicant: Immco Diagnostics, Inc.
Product code: Code MID
Advisory panel: Immunology
Date received: 2011-10-11
Decision date: 2012-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

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