FDA 510(k) Applications for Medical Device Product Code "OMI"
(Multiplex Flow Immunoassay, T.Gondii, Rubella And Cmv.)

FDA 510(k) Number Applicant Device Name Decision Date
K080008 BIO-RAD LABORATORIES, INC. BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET 02/23/2009
K120572 BIO-RAD LABORATORIES, INC. BIOPLEX 2200 TORC IGG 03/26/2012


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