I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER

I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER is an FDA 510(k)-cleared medical device (K001154) manufactured by I-Stat Corp.. 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 April 17, 2000. Regulation: 8.