510(k) K111072
- Device
- BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL
- Applicant
- Bio-Rad Laboratories
- 510(k) number
- K111072
- Product code
- OPL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-08-23
- Date received
- 2011-04-18
- Regulation
- 866.3510
- Classification name
- Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Juang Wang
- Address
- 5500 E. 2nd St. Benicia CA US 94510 94510
FDA Registration Numbers#
- 3032705
- 2915274
Source Documents#
Other 510(k) Records For Product Code OPL #
Legacy Summary#
summary
FDA Review#
Decision Summary