K091284 is an FDA 510(k) clearance for the VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA. This device is classified as a Plasma, Coagulation Control (Class II - Special Controls, product code GGN).
Submitted by Affinity Biologicals, Inc. (Ancaster, Ontario, CA). The FDA issued a Cleared decision on October 28, 2009, 180 days after receiving the submission on May 1, 2009.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K091284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2009 |
| Decision Date | October 28, 2009 |
| Days to Decision | 180 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GGN — Plasma, Coagulation Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |