Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K160429
BC-5390 Auto Hematology Analyzer · Mindray Bio-Medical Electronics Co., Ltd. · decided 2016-09-01 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| 0.5ml tube adpater | 115-041604-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | GKZ | 06944904084374 |
| Auto Hematology Analyzer(FDA) BC-3600 | BC-3600 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | GKZ | 06944904027883 |
| Tube rack module | 115-041599-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | GKZ | 06944904084367 |