510(k) K170509
- Device
- BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
- Applicant
- Bio-Rad Laboratories
- 510(k) number
- K170509
- Product code
- PUQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-05-19
- Date received
- 2017-02-21
- Regulation
- 866.3510
- Classification name
- Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Arlene Carillo
- Address
- 5500 E. Second St. Benicia CA US 94510 94510
FDA Registration Numbers#
- 3032705
- 2915274
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary