K181751 is an FDA 510(k) clearance for the HemoCue Hb 801 System. This device is classified as a System, Hemoglobin, Automated (Class II - Special Controls, product code GKR).
Submitted by Hemocue AB (Ängelholm, SE). The FDA issued a Cleared decision on February 1, 2019, 214 days after receiving the submission on July 2, 2018.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5620.
| 510(k) Number | K181751 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2018 |
| Decision Date | February 01, 2019 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKR - System, Hemoglobin, Automated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5620 |