K042760 is an FDA 510(k) clearance for the PEFAKIT APC-R FACTOR V LEIDEN CONTROLS. This device is classified as a Plasma, Coagulation Control (Class II - Special Controls, product code GGN).
Submitted by Pentapharm , Ltd. (Washington, US). The FDA issued a Cleared decision on December 22, 2004, 78 days after receiving the submission on October 5, 2004.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K042760 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2004 |
| Decision Date | December 22, 2004 |
| Days to Decision | 78 days |
| Submission Type | Abbreviated |
| 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 |