
Teco Diagnostics, Inc.
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URITEK TC-201 URINE CHEMISTRY TEST SYSTEM is an FDA 510(k)-cleared medical device (K152835) manufactured by Teco Diagnostics, Inc.. 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 March 6, 2016. Regulation: 8.