The following data is part of a premarket notification filed by Biomira Diagnostics, Inc. with the FDA for Visuwell Reagin Ii.
| Device ID | K952802 |
| 510k Number | K952802 |
| Device Name: | VISUWELL REAGIN II |
| Classification | Antigens, Nontreponemal, All |
| 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 | GMQ |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-19 |
| Decision Date | 1996-05-23 |
| Summary: | summary |