K981950 is an FDA 510(k) clearance for the SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500. This device is classified as a Counter, Cell, Automated (particle Counter) (Class II - Special Controls, product code GKL).
Submitted by Sysmex Corp. (Long Grove, US). The FDA issued a Cleared decision on November 3, 1998, 153 days after receiving the submission on June 3, 1998.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5200.
| 510(k) Number | K981950 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 1998 |
| Decision Date | November 03, 1998 |
| Days to Decision | 153 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 |