
Cliniqa Corporation
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I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 is an FDA 510(k)-cleared medical device (K120900) manufactured by Cliniqa Corporation. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 30, 2013. Regulation: 8.