K043184 is an FDA 510(k) clearance for the HEMOSIL RECOMBIPLASTIN. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on December 22, 2004, 35 days after receiving the submission on November 17, 2004.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.
| 510(k) Number | K043184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2004 |
| Decision Date | December 22, 2004 |
| Days to Decision | 35 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GJS — Test, Time, Prothrombin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7750 |