The following data is part of a premarket notification filed by Biomira Diagnostics, Inc. with the FDA for Visuwell Syphilis Antibody.
| Device ID | K932453 |
| 510k Number | K932453 |
| Device Name: | VISUWELL SYPHILIS ANTIBODY |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | BIOMIRA DIAGNOSTICS, INC. 30 MERIDIAN RD. Rexdale, Ontario, CA M9w 4z7 |
| Contact | Althea R Lawrence |
| Correspondent | Althea R Lawrence BIOMIRA DIAGNOSTICS, INC. 30 MERIDIAN RD. 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 | 1993-05-20 |
| Decision Date | 1995-07-11 |