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.

Clearance details

Applicant: Orgentec Diagnostika GmbH
Product code: Code LJM
Advisory panel: Immunology
Date received: 2003-03-24
Decision date: 2003-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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