510(k) K953761

AXSYM TRICYCLIC ANTIDEPRESSANTS by Abbott Laboratories — Product Code LFH

K953761 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "AXSYM TRICYCLIC ANTIDEPRESSANTS". The FDA issued a decision of Substantially Equivalent on November 22, 1995. The device falls under product code LFH (U.V. Spectrometry, Tricyclic Antidepressant Drugs), a Class II device regulated under 21 CFR 862.3910. Abbott Laboratories has at least 10 other 510(k) clearances on record.