510(k) K080008
- Device
- BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
- Applicant
- BIO-RAD LABORATORIES, INC.
- 510(k) number
- K080008
- Product code
- OMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-02-23
- Date received
- 2008-01-02
- Regulation
- 866.3510
- Classification name
- Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CYNTHIA SINCLAIR
- Address
- 49 Plain St. North Attleboro MA US 02760 02760
FDA Registration Numbers#
- 3032705
- 2915274
Source Documents#
Other 510(k) Records For Product Code OMI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K120572 | BIOPLEX 2200 TORC IGG | Bio-Rad Laboratories, Inc. | 2012-03-26 |
Legacy Summary#
summary
FDA Review#
Decision Summary