510(k) K120572
- Device
- BIOPLEX 2200 TORC IGG
- Applicant
- BIO-RAD LABORATORIES, INC.
- 510(k) number
- K120572
- Product code
- OMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-03-26
- Date received
- 2012-02-27
- Regulation
- 866.3510
- Classification name
- Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
- 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 OMI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080008 | BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET | Bio-Rad Laboratories, Inc. | 2009-02-23 |
Legacy Summary#
summary
FDA Review#
Decision Summary