510(k) K940817

TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II by Abbott Laboratories — Product Code JHF

K940817 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II". The FDA issued a decision of Substantially Equivalent on February 8, 1995. The device falls under product code JHF (Colorimetric Method, Lecithin/Sphingomyelin Ratio), a Class II device regulated under 21 CFR 862.1455. Abbott Laboratories has at least 10 other 510(k) clearances on record.