IFA 40: HEP-20-10— 510(k) K131791

Substantially Equivalent

Euroimmun US

FDA 510(k) clearance K131791 for IFA 40: HEP-20-10, Substantially Equivalent on 2014-02-26. Applicant: Euroimmun US. Device class: 2.

Clearance details

Applicant: Euroimmun US
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2013-06-18
Decision date: 2014-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morris Plains, NJ, US

Download summary PDF View on FDA.gov ↗

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