I-STAT 200 PORTABLE CLINICAL ANALYZER

I-STAT 200 PORTABLE CLINICAL ANALYZER is an FDA 510(k)-cleared medical device (K940918) 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 May 9, 1994. Regulation: 8.