The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 Mmrv Igg.
| Device ID | K091616 |
| 510k Number | K091616 |
| Device Name: | BIOPLEX 2200 MMRV IGG |
| Classification | Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus |
| Applicant | Bio-Rad Laboratories 6565 185TH AVE, NE Redmond, WA 98052 |
| Contact | David Bhend |
| Correspondent | David Bhend Bio-Rad Laboratories 6565 185TH AVE, NE Redmond, WA 98052 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-03 |
| Decision Date | 2010-03-29 |
| Summary: | summary |