Submission Details
| 510(k) Number | K140690 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 19, 2014 |
| Decision Date | September 02, 2014 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER
Sep 2014
Decision
167d
Days
Class 2
Risk
About This 510(k) Submission
K140690 is an FDA 510(k) clearance for the BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on September 2, 2014, 167 days after receiving the submission on March 19, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.
Device Classification
| Product Code | CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1770 |
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Great Neck, NY · US
SUSAN D GOLDSTEIN-FALK
154 submissions
154 cleared
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