K050661 is an FDA 510(k) clearance for the HEMOSIL FACTOR II DEFICIENT PLASMA. This device is classified as a Plasma, Coagulation Factor Deficient (Class II - Special Controls, product code GJT).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on May 2, 2005, 48 days after receiving the submission on March 15, 2005.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7290.
| 510(k) Number | K050661 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2005 |
| Decision Date | May 02, 2005 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GJT — Plasma, Coagulation Factor Deficient |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7290 |