K110031 is an FDA 510(k) clearance for the HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM. This device is classified as a Reagent, Russel Viper Venom (Class I - General Controls, product code GIR).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on August 24, 2011, 231 days after receiving the submission on January 5, 2011.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8950.
| 510(k) Number | K110031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2011 |
| Decision Date | August 24, 2011 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GIR — Reagent, Russel Viper Venom |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.8950 |