K034007 is an FDA 510(k) clearance for the HEMOSIL FACTOR VIII 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 February 13, 2004, 51 days after receiving the submission on December 24, 2003.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7290.
| 510(k) Number | K034007 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 2003 |
| Decision Date | February 13, 2004 |
| Days to Decision | 51 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 |