MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK

MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK is an FDA 510(k)-cleared medical device (K894914) 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 October 15, 1989. Regulation: 8.