K100499

Substantially Equivalent

ORGENTEC RHEUMATOID FACTOR EIA

Applicant: Orgentec Diagnostika GmbH
Product code: DHR
Advisory panel: Immunology
Date received: 2010-02-22
Decision date: 2010-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

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