K113211 is an FDA 510(k) clearance for the HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL. 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 January 4, 2012, 65 days after receiving the submission on October 31, 2011.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K113211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2011 |
| Decision Date | January 04, 2012 |
| Days to Decision | 65 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 |