The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 Hsv-1 And Hsv-2 Igg Kit.
| Device ID | K120959 |
| 510k Number | K120959 |
| Device Name: | BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Applicant | Bio-Rad Laboratories BIOPLEX 2200 DIVISION 5500 EAST SECOND ST Benicia, CA 94510 |
| Contact | Juang Wang |
| Correspondent | Juang Wang Bio-Rad Laboratories BIOPLEX 2200 DIVISION 5500 EAST SECOND ST Benicia, CA 94510 |
| Product Code | MXJ |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| Subsequent Product Code | MYF |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-30 |
| Decision Date | 2012-06-22 |
| Summary: | summary |