FDA 510(k) Applications for Medical Device Product Code "OPL"
|
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 |