K213464 is an FDA 510(k) clearance for the HemosIL Liquid Anti-Xa. This device is classified as a Assay, Heparin (Class II - Special Controls, product code KFF).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on October 4, 2022, 341 days after receiving the submission on October 28, 2021.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7525.
| 510(k) Number | K213464 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2021 |
| Decision Date | October 04, 2022 |
| Days to Decision | 341 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | KFF — Assay, Heparin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7525 |