K870233 is an FDA 510(k) clearance for the CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. 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 March 17, 1987, 55 days after receiving the submission on January 21, 1987.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K870233 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 1987 |
| Decision Date | March 17, 1987 |
| Days to Decision | 55 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 |