ORGENTEC RHEUMATOID FACTOR EIA— 510(k) K100499

Name: FDA 510(k) clearance K100499
Creator: U.S. Food and Drug Administration
Published: 2010-10-27

Substantially Equivalent

Orgentec Diagnostika GmbH

FDA 510(k) clearance K100499 for ORGENTEC RHEUMATOID FACTOR EIA, Substantially Equivalent on 2010-10-27. Applicant: Orgentec Diagnostika GmbH. Device class: 2.

Clearance details

Applicant: Orgentec Diagnostika GmbH
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 2010-02-22
Decision date: 2010-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, 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.