Anti-Mutated Citrullinated Vimentin Eia

FDA 510(k) K092399 · Orgentec Diagnostika GmbH

Substantially Equivalent

510(k) numberK092399

Submission

Device name
Anti-Mutated Citrullinated Vimentin Eia
Applicant
Orgentec Diagnostika GmbH
East Stroudsburg, PA, US
Received
August 6, 2009
Decision date
July 1, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OQZ – Anti-Mutated Citrullinated Vimentin Igg
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5775
Specialty
Immunology

For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma.

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Questions and answers

When was Anti-Mutated Citrullinated Vimentin Eia cleared by the FDA?

Anti-Mutated Citrullinated Vimentin Eia (K092399) received a 510(k) decision of Substantially Equivalent on July 1, 2010, 329 days after the submission was received.

What is the product code of K092399?

The FDA product code is OQZ – Anti-Mutated Citrullinated Vimentin Igg, a Class II (moderate risk) device regulated under 21 CFR 866.5775.