K133582 is an FDA 510(k) clearance for the HEMOSIL D-DIMER HS 500 CONTROL. This device is classified as a Plasma, Coagulation Control (Class II - Special Controls, product code GGN).
Submitted by Instrumentation Laboratory (Bedford, US). The FDA issued a Cleared decision on August 15, 2014, 267 days after receiving the submission on November 21, 2013.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K133582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2013 |
| Decision Date | August 15, 2014 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GGN - Plasma, Coagulation Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |