510(k) K030057

SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST by Spectral Diagnostics, Inc. — Product Code MMI

K030057 is an FDA 510(k) premarket notification submitted by Spectral Diagnostics, Inc. for the device "SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST". The FDA issued a decision of Substantially Equivalent on March 19, 2003. 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.