The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Bs-400 Chemistry Analyzer, Clc 720 Chemistry Analyzer.
| Device ID | K112377 |
| 510k Number | K112377 |
| Device Name: | BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER |
| Classification | Hexokinase, Glucose |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | CFR |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-17 |
| Decision Date | 2012-03-23 |
| Summary: | summary |