
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER is an FDA 510(k)-cleared medical device (K140690) manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 1, 2014. Regulation: 8.