FDA 510(k) Applications for Medical Device Product Code "OPL"
(Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus )

FDA 510(k) Number Applicant Device Name Decision Date
K091616 Bio-Rad Laboratories BIOPLEX 2200 MMRV IGG 03/29/2010
K111072 Bio-Rad Laboratories BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL 08/23/2011
K212769 Dynex Technologies Inc. DYNEX SmartPLEX MMRV IgG Assay Kit 09/29/2023


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