K070005 is an FDA 510(k) clearance for the HEMOSIL RECOMBIPLASTIN 2G. 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 August 15, 2007, 224 days after receiving the submission on January 3, 2007.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.
| 510(k) Number | K070005 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2007 |
| Decision Date | August 15, 2007 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| 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 |