K854368 is an FDA 510(k) clearance for the CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Abbott Diagnostics (Mountain View, US). The FDA issued a Cleared decision on January 1, 1986, 64 days after receiving the submission on October 29, 1985.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K854368 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 1985 |
| Decision Date | January 01, 1986 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GKZ — Counter, Differential Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |