510(k) K992127

CARDIOQUANT TROPONIN I TEST by Spectral Diagnostics, Inc. — Product Code MMI

K992127 is an FDA 510(k) premarket notification submitted by Spectral Diagnostics, Inc. for the device "CARDIOQUANT TROPONIN I TEST". The FDA issued a decision of Substantially Equivalent on October 4, 1999. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. Spectral Diagnostics, Inc. has at least 10 other 510(k) clearances on record.