The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Hsv-1 Igg Immunoassay Elecsys Precicontrol Hsv.
| Device ID | K120625 |
| 510k Number | K120625 |
| Device Name: | ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | K. Colleen Adams |
| Correspondent | K. Colleen Adams Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | MXJ |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-01 |
| Decision Date | 2012-07-25 |
| Summary: | summary |