510(k) K944923

CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3, by Clinical Controls, Inc. — Product Code JJT

K944923 is an FDA 510(k) premarket notification submitted by Clinical Controls, Inc. for the device "CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3,". The FDA issued a decision of Substantially Equivalent on Nov 4, 1994. The device falls under product code JJT (Enzyme Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Clinical Controls, Inc. has 17 other 510(k) clearances on record.