The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Syphilis.
| Device ID | K160910 |
| 510k Number | K160910 |
| Device Name: | Elecsys Syphilis |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | ROCHE DIAGNOSTICS 9115 HAGUE RD Indianapolis, IN 46250 |
| Contact | Angelo Pereira |
| Correspondent | Angelo Pereira ROCHE DIAGNOSTICS 9115 HAGUE RD Indianapolis, IN 46250 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-01 |
| Decision Date | 2016-07-28 |
| Summary: | summary |