The following data is part of a premarket notification filed by Adi Diagnostics, Inc. with the FDA for Visuwell Syphilis Antigen.
| Device ID | K910487 |
| 510k Number | K910487 |
| Device Name: | VISUWELL SYPHILIS ANTIGEN |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | ADI DIAGNOSTICS, INC. 30 MERIDIAN ROAD Rexdale, Ontario, CA M9w 4z7 |
| Contact | Heather Smith |
| Correspondent | Heather Smith ADI DIAGNOSTICS, INC. 30 MERIDIAN ROAD Rexdale, Ontario, CA M9w 4z7 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-06 |
| Decision Date | 1991-06-24 |