K063407 is an FDA 510(k) clearance for the BC-3200 AUTO HEMATOLOGY ANALYZER. 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 June 11, 2007, 214 days after receiving the submission on November 9, 2006.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K063407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2006 |
| Decision Date | June 11, 2007 |
| Days to Decision | 214 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 |