The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 Mmrv Igg It On Bioplex 2200 Multi-analyte Detection System, Bioplex 2200 Mmrv Igg Calibrator Set, And Biopl.
| Device ID | K111072 |
| 510k Number | K111072 |
| Device Name: | BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL |
| Classification | Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus |
| Applicant | Bio-Rad Laboratories 5500 E. 2nd Street Benicia, CA 94510 |
| Contact | Juang Wang |
| Correspondent | Juang Wang Bio-Rad Laboratories 5500 E. 2nd Street Benicia, CA 94510 |
| Product Code | OPL |
| Subsequent Product Code | LFY |
| Subsequent Product Code | LJB |
| Subsequent Product Code | LJY |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-18 |
| Decision Date | 2011-08-23 |
| Summary: | summary |