
Cala Diagnostics
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CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ is an FDA 510(k)-cleared medical device (K850907) manufactured by Cala Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 24, 1985. Regulation: 8.