510(k) K030964

CALIBRATION PLASMA LMW HEPARIN by Instrumentation Laboratory CO — Product Code JIS

K030964 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "CALIBRATION PLASMA LMW HEPARIN". The FDA issued a decision of Substantially Equivalent on June 6, 2003. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.