
Diamond Sensor Systems
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GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK. is an FDA 510(k)-cleared medical device (K882450) manufactured by Diamond Sensor Systems. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 27, 1988. Regulation: 8.