510(k) K871593

TDXR FETAL LUNG MATURITY by Abbott Laboratories — Product Code JHG

K871593 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDXR FETAL LUNG MATURITY". The FDA issued a decision of Substantially Equivalent on July 20, 1987. The device falls under product code JHG (Chromatographic Separation, 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.