K140911 is an FDA 510(k) clearance for the UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on September 5, 2014, 149 days after receiving the submission on April 9, 2014.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K140911 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2014 |
| Decision Date | September 05, 2014 |
| Days to Decision | 149 days |
| Submission Type | Abbreviated |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKZ — Counter, Differential Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |