The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Bs-480 Chemistry Analyzer, Bs-490 Chemistry Analyzer, Clc720i Chemistry Analyzer.
| Device ID | K140690 |
| 510k Number | K140690 |
| Device Name: | BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| 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 | CDQ |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-19 |
| Decision Date | 2014-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904086910 | K140690 | 000 |
| 06944904086903 | K140690 | 000 |
| 06944904084527 | K140690 | 000 |
| 06944904084497 | K140690 | 000 |
| 06944904084442 | K140690 | 000 |
| 06944904038162 | K140690 | 000 |