The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 Torc Igm, Bioplex 2200 Torc Igm Calibrator Set, Bioplex 2200 Torc Igm Control Set.
| Device ID | K170509 |
| 510k Number | K170509 |
| Device Name: | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set |
| Classification | Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm |
| Applicant | Bio-Rad Laboratories 5500 East Second Street Benicia, CA 94510 |
| Contact | Arlene Carillo |
| Correspondent | Arlene Carillo Bio-Rad Laboratories 5500 East Second Street Benicia, CA 94510 |
| Product Code | PUQ |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFZ |
| Subsequent Product Code | LGD |
| Subsequent Product Code | LKQ |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-21 |
| Decision Date | 2017-05-19 |
| Summary: | summary |