K081104

Substantially Equivalent

AESKULISA ANA HEP-2, REF 30-7115US

Applicant: Aesku Diagnostics
Product code: LKJ
Advisory panel: Immunology
Date received: 2008-04-18
Decision date: 2008-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wendelsheim, Rheinland, DE

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