K162540 is an FDA 510(k) clearance for the INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls. This device is classified as a Assay, Heparin (Class II - Special Controls, product code KFF).
Submitted by Siemens Healthcare Diagnostics Prodcts GmbH (Marburg, DE). The FDA issued a Cleared decision on August 22, 2017, 344 days after receiving the submission on September 12, 2016.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7525.
| 510(k) Number | K162540 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2016 |
| Decision Date | August 22, 2017 |
| Days to Decision | 344 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | KFF — Assay, Heparin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7525 |