The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Bioplex 2200 System Torc Igg Kit, Calibrator Set And Control Set.
| Device ID | K080008 |
| 510k Number | K080008 |
| Device Name: | BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET |
| Classification | Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv |
| Applicant | BIO-RAD LABORATORIES, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia Sinclair |
| Correspondent | Cynthia Sinclair BIO-RAD LABORATORIES, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | OMI |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-02 |
| Decision Date | 2009-02-23 |
| Summary: | summary |