K032677 is an FDA 510(k) clearance for the SYSMEX POCH-100I. This device is classified as a Counter, Cell, Automated (particle Counter) (Class II - Special Controls, product code GKL).
Submitted by Sysmex America, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 11, 2004, 166 days after receiving the submission on August 29, 2003.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5200.
| 510(k) Number | K032677 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2003 |
| Decision Date | February 11, 2004 |
| Days to Decision | 166 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 |