K141161 is an FDA 510(k) clearance for the ABX MICROS ES 60 CT. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by HORIBA ABX SAS (Montpellier, FR). The FDA issued a Cleared decision on December 20, 2014, 229 days after receiving the submission on May 5, 2014.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K141161 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2014 |
| Decision Date | December 20, 2014 |
| Days to Decision | 229 days |
| Submission Type | Traditional |
| 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 |