The following data is part of a premarket notification filed by Affinity Biologicals Inc. with the FDA for Visucal-f Frozen Calibrator Plasma And Visucon-f Frozen Normal And Abnormal Control Plasma.
| Device ID | K091284 |
| 510k Number | K091284 |
| Device Name: | VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA |
| Classification | Plasma, Coagulation Control |
| 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 | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-01 |
| Decision Date | 2009-10-28 |
| Summary: | summary |