510(k) K974779

ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER by Abbott Laboratories — Product Code JJE

K974779 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER". The FDA issued a decision of Substantially Equivalent on February 13, 1998. The device falls under product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use), a Class I device regulated under 21 CFR 862.2160. Abbott Laboratories has at least 10 other 510(k) clearances on record.