The following data is part of a premarket notification filed by Mindray Bio-medical Electronics Co., Ltd with the FDA for Bc-5390 Auto Hematology Analyzer.
| Device ID | K160429 |
| 510k Number | K160429 |
| Device Name: | BC-5390 Auto Hematology Analyzer |
| Classification | Counter, Differential Cell |
| Applicant | MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KEJI 12TH RD SOUTH, HI-TECH INDUSTRIAL PARK Nanshan, CN 518057 |
| Contact | Min Zheng |
| Correspondent | Jinjie Hu Biologics Consulting 400 N. WASHINGTON ST, 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 | 2016-02-16 |
| Decision Date | 2016-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904084374 | K160429 | 000 |
| 06944904084367 | K160429 | 000 |
| 06944904027883 | K160429 | 000 |