510(k) K873903

ABBOTT PAP-EIA by Abbott Laboratories — Product Code JFH

K873903 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT PAP-EIA". The FDA issued a decision of Substantially Equivalent on December 1, 1987. The device falls under product code JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited), a Class II device regulated under 21 CFR 862.1020. Abbott Laboratories has at least 10 other 510(k) clearances on record.