K082859 is an FDA 510(k) clearance for the HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED. This device is classified as a Plasma, Coagulation Control (Class II - Special Controls, product code GGN).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on December 19, 2008, 81 days after receiving the submission on September 29, 2008.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K082859 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2008 |
| Decision Date | December 19, 2008 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| 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 |