
Tianjin New Bay Bioresearch Co., Ltd.
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FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST is an FDA 510(k)-cleared medical device (K061617) manufactured by Tianjin New Bay Bioresearch Co., Ltd.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 21, 2006. Regulation: 8.