EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)— 510(k) K091969

Name: FDA 510(k) clearance K091969
Creator: U.S. Food and Drug Administration
Published: 2010-09-02

Substantially Equivalent

Euroimmun Us, Inc.

FDA 510(k) clearance K091969 for EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG), Substantially Equivalent on 2010-09-02. Applicant: Euroimmun Us, Inc.. Device class: 2.

Clearance details

Applicant: Euroimmun Us, Inc.
Product code: Code NBO
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2009-07-01
Decision date: 2010-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morristown, NJ, US

Download summary PDF View on FDA.gov ↗

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