EUROIMMUN ANA IFA: HEP-20-10— 510(k) K070763

Substantially Equivalent

Euroimmun Us, LLC

FDA 510(k) clearance K070763 for EUROIMMUN ANA IFA: HEP-20-10, Substantially Equivalent on 2007-05-22. Applicant: Euroimmun Us, LLC. Device class: 2.

Clearance details

Applicant: Euroimmun Us, LLC
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2007-03-20
Decision date: 2007-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boonton Township, NJ, US

Download summary PDF View on FDA.gov ↗

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