AESKU PR3— 510(k) K091859

Substantially Equivalent

Aesku Diagnostics

FDA 510(k) clearance K091859 for AESKU PR3, Substantially Equivalent on 2010-06-03. Applicant: Aesku Diagnostics.

Clearance details

Applicant: Aesku Diagnostics
Product code: Code MOB
Advisory panel: Immunology
Date received: 2009-06-19
Decision date: 2010-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wendelsheim, Rheinland, DE

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