ANA DETECT— 510(k) K030929

Substantially Equivalent

Orgentec Diagnostika GmbH

FDA 510(k) clearance K030929 for ANA DETECT, Substantially Equivalent on 2003-05-02. Applicant: Orgentec Diagnostika GmbH. Device class: 2.

Clearance details

Applicant: Orgentec Diagnostika GmbH
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2003-03-24
Decision date: 2003-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.