The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 Ebv Igm Kit.
| Device ID | K123021 |
| 510k Number | K123021 |
| Device Name: | BIOPLEX 2200 EBV IGM KIT |
| Classification | Antibody Igm, If, Epstein-barr Virus |
| Applicant | Bio-Rad Laboratories 5500 SECOND ST Benicia, CA 94510 |
| Contact | Juang Wang |
| Correspondent | Juang Wang Bio-Rad Laboratories 5500 SECOND ST Benicia, CA 94510 |
| Product Code | LJN |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| Subsequent Product Code | KTN |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-27 |
| Decision Date | 2012-11-02 |
| Summary: | summary |