510(k) K900806

STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY by Baxter Healthcare Corp — Product Code JHS

K900806 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on March 23, 1990. The device falls under product code JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.