The following data is part of a premarket notification filed by Affinity Biologicals Inc. with the FDA for Visulize Factor Viii Antigen Kit, Model Fviii-ag.
| Device ID | K052825 |
| 510k Number | K052825 |
| Device Name: | VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | AFFINITY BIOLOGICALS INC. 1395 SANDHILL DRIVE Ancaster, Ontario, CA L9g 4v5 |
| Contact | Denise Foulon |
| Correspondent | Denise Foulon AFFINITY BIOLOGICALS INC. 1395 SANDHILL DRIVE Ancaster, Ontario, CA L9g 4v5 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-05 |
| Decision Date | 2006-01-20 |
| Summary: | summary |