The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Bioplex 2200 Torc Igg.
| Device ID | K120572 |
| 510k Number | K120572 |
| Device Name: | BIOPLEX 2200 TORC IGG |
| Classification | Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv |
| Applicant | BIO-RAD LABORATORIES, INC. 5500 EAST 2ND ST. Benicia, CA 94510 |
| Contact | Juang Wang |
| Correspondent | Juang Wang BIO-RAD LABORATORIES, INC. 5500 EAST 2ND ST. Benicia, CA 94510 |
| Product Code | OMI |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-27 |
| Decision Date | 2012-03-26 |
| Summary: | summary |