DeviceClearance

AESKULISA ANA HEP-2, REF 30-7115US— 510(k) K081104

Substantially Equivalent

Aesku Diagnostics

FDA 510(k) clearance K081104 for AESKULISA ANA HEP-2, REF 30-7115US, Substantially Equivalent on 2008-05-02. Applicant: Aesku Diagnostics.

Clearance details

Applicant
Aesku Diagnostics
Product code
Code LKJ
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wendelsheim, Rheinland, DE
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.