510(k) K945271

ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM by Bio-Chem Laboratory Systems, Inc. — Product Code JJE

K945271 is an FDA 510(k) premarket notification submitted by Bio-Chem Laboratory Systems, Inc. for the device "ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 20, 1995. The device falls under product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use), a Class I device regulated under 21 CFR 862.2160. Bio-Chem Laboratory Systems, Inc. has at least 4 other 510(k) clearances on record.