K093394 is an FDA 510(k) clearance for the BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on April 8, 2010, 160 days after receiving the submission on October 30, 2009.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K093394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2009 |
| Decision Date | April 08, 2010 |
| Days to Decision | 160 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 |