510(k) K973668

CARDIAC TROPONIN-I (TROP) CALIBRATOR by Dade Intl., Inc. — Product Code JIT

K973668 is an FDA 510(k) premarket notification submitted by Dade Intl., Inc. for the device "CARDIAC TROPONIN-I (TROP) CALIBRATOR". The FDA issued a decision of Substantially Equivalent on October 20, 1997. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Dade Intl., Inc. has at least 10 other 510(k) clearances on record.