The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Syphilis.
| Device ID | K211302 |
| 510k Number | K211302 |
| Device Name: | Elecsys Syphilis |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Bin Sun |
| Correspondent | Bin Sun Roche Diagnostics 9115 Hague Road 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 | 2021-04-29 |
| Decision Date | 2021-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336171998 | K211302 | 000 |
| 07613336171950 | K211302 | 000 |