K103313 is an FDA 510(k) clearance for the HEPARIN ASSAY CONTROLS. This device is classified as a Plasma, Coagulation Control (Class II - Special Controls, product code GGN).
Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on December 1, 2010, 21 days after receiving the submission on November 10, 2010.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K103313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 2010 |
| Decision Date | December 01, 2010 |
| Days to Decision | 21 days |
| Submission Type | Special |
| 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 |