K071652 is an FDA 510(k) clearance for the HEMOCUE WBC SYSTEM. This device is classified as a Counter, Cell, Automated (particle Counter) (Class II - Special Controls, product code GKL).
Submitted by Hemocue AB (Lake Forest, US). The FDA issued a Cleared decision on October 25, 2007, 129 days after receiving the submission on June 18, 2007.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5200.
| 510(k) Number | K071652 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2007 |
| Decision Date | October 25, 2007 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKL - Counter, Cell, Automated (particle Counter) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5200 |