The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 Syphilis Total & Rpr, Bioplex 2200 Syphilis Total & Rpr Calibrator Set, Bioplex 2200 Syphilis Total & Rpr Control Set.
| Device ID | K170413 |
| 510k Number | K170413 |
| Device Name: | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | Bio-Rad Laboratories 5500 E. 2nd Street Benicia, CA 94510 |
| Contact | Juang Wang |
| Correspondent | Juang Wang Bio-Rad Laboratories 5500 E. 2nd Street Benicia, CA 94510 |
| Product Code | LIP |
| Subsequent Product Code | GMQ |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-10 |
| Decision Date | 2017-05-11 |
| Summary: | summary |