K052825 is an FDA 510(k) clearance for the VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG. This device is classified as a Test, Qualitative And Quantitative Factor Deficiency (Class II - Special Controls, product code GGP).
Submitted by Affinity Biologicals, Inc. (Ancaster, Ontario, CA). The FDA issued a Cleared decision on January 20, 2006, 107 days after receiving the submission on October 5, 2005.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7290.
| 510(k) Number | K052825 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2005 |
| Decision Date | January 20, 2006 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GGP — Test, Qualitative And Quantitative Factor Deficiency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7290 |