510(k) K952427

CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE by Beckman Instruments, Inc. — Product Code CKA

K952427 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE". The FDA issued a decision of Substantially Equivalent on September 21, 1995. The device falls under product code CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.