AESKUSLIDES ANA HEP-2— 510(k) K120889

Substantially Equivalent

Aesku Diagnostics

FDA 510(k) clearance K120889 for AESKUSLIDES ANA HEP-2, Substantially Equivalent on 2012-10-15. Applicant: Aesku Diagnostics.

Clearance details

Applicant: Aesku Diagnostics
Product code: Code DHN
Advisory panel: Immunology
Date received: 2012-03-23
Decision date: 2012-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pedricktown, NJ, US

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