FDA 510(k) Applications for Medical Device Product Code "DHC"
(System, Test, Systemic Lupus Erythematosus)

FDA 510(k) Number Applicant Device Name Decision Date
K001352 CORGENIX, INC. REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT 04/09/2001
K001398 CORGENIX, INC. REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT 03/30/2001


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