ANTI-MUTATED CITRULLINATED VIMENTIN EIA— 510(k) K092399

Name: FDA 510(k) clearance K092399
Creator: U.S. Food and Drug Administration
Published: 2010-07-01

Substantially Equivalent

Orgentec Diagnostika GmbH

FDA 510(k) clearance K092399 for ANTI-MUTATED CITRULLINATED VIMENTIN EIA, Substantially Equivalent on 2010-07-01. Applicant: Orgentec Diagnostika GmbH. Device class: 2.

Clearance details

Applicant: Orgentec Diagnostika GmbH
Product code: Code OQZ
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 2009-08-06
Decision date: 2010-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

Download summary PDF View on FDA.gov ↗

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