
Self Care Systems, Inc.
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MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL is an FDA 510(k)-cleared medical device (K860028) manufactured by Self Care Systems, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 6, 1986. Regulation: 8.