The following data is part of a premarket notification filed by Mindray Bio-medical Electronics Co., Ltd with the FDA for Bc-3600 Auto Hematology Analyzer.
| Device ID | K143348 |
| 510k Number | K143348 |
| Device Name: | BC-3600 Auto Hematology Analyzer |
| Classification | Counter, Differential Cell |
| Applicant | MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Mindray Building, Keji 12th Road South High-tech Industrial Park Shenzhen, CN 518057 |
| Contact | Tan Chuanbin |
| Correspondent | Jinjie Hu BIOLOGICS CONSULTING GROUP, INC. 400 N. WASHINGTON STREET SUITE 100 Alexandria, VA 22314 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-21 |
| Decision Date | 2015-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904052113 | K143348 | 000 |