510(k) K863999

VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 by Leeco Diagnostics, Inc. — Product Code LCX

K863999 is an FDA 510(k) premarket notification submitted by Leeco Diagnostics, Inc. for the device "VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042". The FDA issued a decision of Substantially Equivalent on January 9, 1987. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Leeco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.