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 |