510(k) K993098

HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 by Data Medical Associates, Inc. — Product Code JIX

K993098 is an FDA 510(k) premarket notification submitted by Data Medical Associates, Inc. for the device "HDL-C/LDL-C CALIBRATOR, MODEL 1913-003". The FDA issued a decision of Substantially Equivalent on October 8, 1999. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Data Medical Associates, Inc. has at least 10 other 510(k) clearances on record.