K043080 is an FDA 510(k) clearance for the HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR. This device is classified as a Analyzer, Heparin, Automated (Class II - Special Controls, product code JOX).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on December 3, 2004, 25 days after receiving the submission on November 8, 2004.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5680.
| 510(k) Number | K043080 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2004 |
| Decision Date | December 03, 2004 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JOX — Analyzer, Heparin, Automated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5680 |