The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Bioplex 2200 Ebv Igg And Syphilis Igg.
| Device ID | K120439 |
| 510k Number | K120439 |
| Device Name: | BIOPLEX 2200 EBV IGG AND SYPHILIS IGG |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| 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 | LIP |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| Subsequent Product Code | LSE |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-13 |
| Decision Date | 2012-03-14 |
| Summary: | summary |