The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Hsv-2 Igg (08948887160).
| Device ID | K220924 |
| 510k Number | K220924 |
| Device Name: | Elecsys HSV-2 IgG (08948887160) |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 |
| Applicant | Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250 |
| Contact | Cynthia Aker |
| Correspondent | Cynthia Aker Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250 |
| Product Code | MYF |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-31 |
| Decision Date | 2022-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336170694 | K220924 | 000 |
| 07613336170687 | K220924 | 000 |