
Data Medical Associates, Inc.
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HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 is an FDA 510(k)-cleared medical device (K993098) manufactured by Data Medical Associates, Inc.. 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 7, 1999. Regulation: 8.