Orgentec Rheumatoid Factor Eia

FDA 510(k) K100499 · Orgentec Diagnostika GmbH

Substantially Equivalent

510(k) numberK100499

Submission

Device name
Orgentec Rheumatoid Factor Eia
Applicant
Orgentec Diagnostika GmbH
East Stroudsburg, PA, US
Received
February 22, 2010
Decision date
October 27, 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
DHR – System, Test, Rheumatoid Factor
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5775
Specialty
Immunology

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K182747EliA RF IgM ImmunoassayDHR · Traditional Phadia AB12/18/2018SE
K162263Optilite Rheumatoid Factor KitDHR · Traditional The Binding Site Group , Ltd.05/03/2017SE
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K143736ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA…DHR · Traditional Immco Diagnostics, Inc.09/23/2015SE
K102673Rheumatoid Factor Immunological Test SystemDHR · Traditional Phadia US, Inc.09/30/2011SE
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K071247N Latex RF KitDHR · Traditional Dade Behring, Inc.08/08/2007SE
K060201Olympus RF Latex Calibrator, and Olympus RF Latex Reagent with Model(S): ODC0028, and…DHR · Traditional Olympus America, Inc.06/06/2006SE

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Questions and answers

When was Orgentec Rheumatoid Factor Eia cleared by the FDA?

Orgentec Rheumatoid Factor Eia (K100499) received a 510(k) decision of Substantially Equivalent on October 27, 2010, 247 days after the submission was received.

What is the product code of K100499?

The FDA product code is DHR – System, Test, Rheumatoid Factor, a Class II (moderate risk) device regulated under 21 CFR 866.5775.