K201217 is an FDA 510(k) clearance for the HemoCue Hb 301 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 August 4, 2020, 90 days after receiving the submission on May 6, 2020.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5620.
| 510(k) Number | K201217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2020 |
| Decision Date | August 04, 2020 |
| Days to Decision | 90 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 |