Hycor's arthritis test gets FDA clearance:
This article was originally published in Clinica
Executive Summary
Hycor Biomedical has received 510(k) FDA clearance to market its Rheumatoid Factor (RF) IgA ELISA autoimmune test. The test completes a series of rheumatoid arthritis tests from Hycor and complements the RF IgM and RF IgG tests previously cleared for marketing by the FDA. All tests can be performed using a manual procedure as well as in a fully automated mode on Hycor's new HYoTEC 288 automated immunoassay system, the Garden Grove, California-based company said.