K053308 is an FDA 510(k) clearance for the ABX MICROS CRP 200, OPTION IM. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on December 29, 2005, 31 days after receiving the submission on November 28, 2005.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K053308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2005 |
| Decision Date | December 29, 2005 |
| Days to Decision | 31 days |
| Submission Type | Special |
| 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 |