The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Bc-3200 Auto Hematology Analyzer,m-30d Diluent, M-30r Rinse, M-30cfl Lyse, M-30e-z Cleanser, M-30probe Cleanser, Bc-3d C.
| Device ID | K093394 |
| 510k Number | K093394 |
| Device Name: | BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C |
| Classification | Counter, Differential Cell |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan Goldstein |
| Correspondent | Susan Goldstein SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-30 |
| Decision Date | 2010-04-08 |
| Summary: | summary |